Clinical trial NCT05857644
Conditions: Liver Diseases Hepatic Impairment
Keywords: healthy volunteers
Sponsor: Pfizer
Start date: 2023-06-07; Completion date: 2024-02-07
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe.

This study is seeking participants who:

* are male or female of 18 years of age or older.
* are examined to be healthy (group with no loss of liver function).
* have mild, moderate, and severe liver disease (group with loss of liver function).

All participants will receive a one-time dose of 4 capsules of PF-07923568 which will be taken by mouth. All participants will remain at the study clinic for 6 days for safety review and laboratory collections. This is to see how the study medicine is being broken down by the liver over time.

All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 6 days. On day 6, the participant will be discharged. About 28 to 35 days after discharge, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Detailed description:

Arms: arm 1: One time dose of 4 capsules taken orally. arm 2: One time dose of 4 capsules taken orally. arm 3: One time dose of 4 capsules taken orally arm 4: One time dose of 4 capsules taken orally.
Interventions: intervention 1: PF-07923568
Intervention descriptions: intervention 1: One time dose of 4 capsules taken orally.

Protocol documents:
Prot_000.pdf: 
PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 1
Title Page
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO 
COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT 
PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT 
RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Study Intervention Number:
PF-07923568
Study Intervention Name:
Sisunatovir
US IND Number:
143479
EudraCT/CTIS Number:
NA
ClinicalTrials.gov ID:
Not available
Pediatric Investigational Plan Number:
NA
Protocol Number:
C5241012
Phase:
1
Brief Title: A Study to Investigate the Effects of Hepatic Impairment on the 
Pharmacokinetics of PF-07923568
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 2
Document History
Document
Version Date
Original protocol
23 February 2023
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................8
1. PROTOCOL SUMMARY.....................................................................................................9
1.1. Synopsis ....................................................................................................................9
1.2. Schema ....................................................................................................................15
1.3. Schedule of Activities .............................................................................................16
2. INTRODUCTION ...............................................................................................................19
2.1. Study Rationale .......................................................................................................19
2.2. Background .............................................................................................................19
2.2.1. Nonclinical Pharmacology..........................................................................20
2.2.2. Nonclinical Pharmacokinetics and Metabolism .........................................20
2.2.3. Nonclinical Safety ......................................................................................21
2.2.4. Clinical Overview.......................................................................................22
2.3. Benefit/Risk Assessment.........................................................................................24
2.3.1. Risk Assessment.........................................................................................24
2.3.2. Benefit Assessment.....................................................................................26
2.3.3. Overall Benefit/Risk Conclusion................................................................26
3. OBJECTIVES AND ENDPOINTS.....................................................................................26
4. STUDY DESIGN.................................................................................................................27
4.1. Overall Design.........................................................................................................27
4.2. Scientific Rationale for Study Design.....................................................................28
4.2.1. Choice of Contraception/Barrier Requirements .........................................30
4.2.2. Collection of Retained Research Samples..................................................30
4.3. Justification for Dose ..............................................................................................30
4.4. End of Study Definition ..........................................................................................31
5. STUDY POPULATION......................................................................................................31
5.1. Inclusion Criteria.....................................................................................................31
5.1.1. Participants in All Groups ..........................................................................31
5.1.2. Additional Inclusion Criteria for Group 1 Only (without HI).....................32
5.1.3. Additional Inclusion Criteria for Groups 2-4 Only (Mild, Moderate, 
and Severe HI) .................................................................................................33
5.2. Exclusion Criteria....................................................................................................33
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Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
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5.2.1. Participants in All Groups ..........................................................................33
5.2.2. Additional Exclusion Criteria for Group 1 Only (without HI) ...................35
5.2.3. Additional Exclusion Criteria for Groups 2-4 Only (Mild, Moderate, 
and Severe HI) .................................................................................................36
5.3. Lifestyle Considerations..........................................................................................37
5.3.1. Contraception..............................................................................................37
5.3.2. Meals and Dietary Restrictions...................................................................37
5.3.3. Caffeine, Alcohol, and Tobacco .................................................................38
5.3.4. Activity .......................................................................................................38
5.4. Screen Failures ........................................................................................................39
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................39
6.1. Study Intervention(s) Administered........................................................................39
6.1.1. Administration............................................................................................40
6.2. Preparation, Handling, Storage, and Accountability...............................................40
6.2.1. Preparation and Dispensing........................................................................41
6.3. Assignment to Study Intervention...........................................................................42
6.4. Blinding...................................................................................................................42
6.4.1. Blinding of Participants..............................................................................42
6.4.2. Blinding of Site Personnel..........................................................................42
6.4.3. Blinding of the Sponsor..............................................................................42
6.5. Study Intervention Compliance...............................................................................42
6.6. Dose Modification...................................................................................................43
6.7. Continued Access to Study Intervention After the End of the Study......................43
6.8. Treatment of Overdose............................................................................................43
6.9. Prior and Concomitant Therapy ..............................................................................43
6.9.1. Participants in Group 1 Only (without Hepatic impairment) .....................44
6.9.2. Participants in Groups 2-4 Only (Hepatic Impairment) .............................44
6.9.3. Rescue Medicine.........................................................................................44
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................45
7.1. Discontinuation of Study Intervention ....................................................................45
7.2. Participant Discontinuation/Withdrawal from the Study........................................45
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Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
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7.2.1. Withdrawal of Consent...............................................................................45
7.3. Lost to Follow-up....................................................................................................46
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................46
8.1. Administrative Procedures ......................................................................................46
8.2. Efficacy Assessments..............................................................................................47
8.3. Safety Assessments .................................................................................................47
8.3.1. Physical Examinations................................................................................47
8.3.2. Vital Signs ..................................................................................................48
8.3.2.1. Blood Pressure and Pulse Rate..................................................48
8.3.3. Electrocardiograms.....................................................................................49
8.3.4. Clinical Safety Laboratory Assessments ....................................................49
8.3.5. COVID-19 Specific Assessments...............................................................50
8.3.6. Pregnancy Testing ......................................................................................50
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................50
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......51
8.4.1.1. Reporting SAEs to Pfizer Safety...............................................51
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................52
8.4.2. Method of Detecting AEs and SAEs ..........................................................52
8.4.3. Follow-Up of AEs and SAEs......................................................................52
8.4.4. Regulatory Reporting Requirements for SAEs...........................................53
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................53
8.4.5.1. Exposure During Pregnancy......................................................53
8.4.5.2. Exposure During Breastfeeding ................................................55
8.4.5.3. Occupational Exposure .............................................................55
8.4.6. Cardiovascular and Death Events...............................................................55
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................56
8.4.8. Adverse Events of Special Interest.............................................................56
8.4.8.1. Lack of Efficacy........................................................................56
8.4.9. Medical Device Deficiencies......................................................................56
8.4.10. Medication Errors.....................................................................................56
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Protocol C5241012
Final Protocol, 23 February 2023
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8.5. Pharmacokinetics ....................................................................................................57
8.5.1. Plasma for Analysis of PF-07923568.........................................................57
8.6. Genetics...................................................................................................................58
8.6.1. Specified Genetics ......................................................................................58
8.6.2. Retained Research Samples for Genetics ...................................................58
8.7. Biomarkers ..............................................................................................................58
8.7.1. Specified Gene Expression (RNA) Research .............................................58
8.7.2. Specified Protein Research.........................................................................58
8.7.3. Specified Metabolomic Research ...............................................................58
8.7.4. Retained Research Samples for Biomarkers...............................................58
8.8. Immunogenicity Assessments.................................................................................59
8.9. Health Economics ...................................................................................................59
9. STATISTICAL CONSIDERATIONS ................................................................................59
9.1. Statistical Hypotheses .............................................................................................59
9.2. Analysis Sets ...........................................................................................................59
9.3. Statistical Analyses .................................................................................................60
9.3.1. General Considerations...............................................................................60
9.3.1.1. Analyses for PK Endpoints .......................................................60
9.3.2. Primary Endpoint(s) Analysis.....................................................................60
9.3.2.1. Definition of Endpoint(s) ..........................................................60
9.3.2.2. Main Analytical Approach........................................................61
9.3.2.3. Supplementary Analyses...........................................................61
9.3.3. Secondary Endpoint Analysis - Safety Analyses........................................62
9.3.3.1. Electrocardiogram Analyses......................................................62
9.3.4. Tertiary/Exploratory Endpoint(s) Analysis ................................................62
9.3.4.1. Biomarkers ................................................................................62
9.3.5. Other Analyses............................................................................................63
9.4. Interim Analyses .....................................................................................................63
9.5. Sample Size Determination.....................................................................................63
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................64
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............64
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Protocol C5241012
Final Protocol, 23 February 2023
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10.1.1. Regulatory and Ethical Considerations ....................................................64
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................64
10.1.2. Financial Disclosure .................................................................................65
10.1.3. Informed Consent Process ........................................................................65
10.1.4. Data Protection .........................................................................................66
10.1.5. Committees Structure ...............................................................................66
10.1.5.1. Data Monitoring Committee ...................................................66
10.1.6. Dissemination of Clinical Study Data ......................................................67
10.1.7. Data Quality Assurance ............................................................................68
10.1.8. Source Documents....................................................................................69
10.1.9. Study and Site Start and Closure ..............................................................69
10.1.10. Publication Policy...................................................................................70
10.1.11. Sponsor’s Medically Qualified Individual..............................................71
10.2. Appendix 2: Clinical Laboratory Tests .................................................................72
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................73
10.3.1. Definition of AE .......................................................................................73
10.3.2. Definition of an SAE ................................................................................74
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................76
10.3.4. Reporting of SAEs....................................................................................79
10.4. Appendix 4: Contraceptive and Barrier Guidance ................................................80
10.4.1. Male Participant Reproductive Inclusion Criteria....................................80
10.4.2. Female Participant Reproductive Inclusion Criteria.................................81
10.4.3. Woman of Childbearing Potential ............................................................81
10.4.4. Contraception Methods.............................................................................82
10.5. Appendix 5: Genetics............................................................................................84
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments .......85
10.7. Appendix 7: Kidney Safety: Monitoring Guidelines ............................................87
10.7.1. Laboratory Assessment of Change in Kidney Function and 
Detection of Kidney Injury..............................................................................87
10.7.2. Age-Specific Kidney Function Calculation Recommendations...............87
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Protocol C5241012
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10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI 
Equations9..........................................................................................87
10.7.3. Adverse Event Grading for Kidney Safety Laboratory 
Abnormalities...................................................................................................87
10.8. Appendix 8: ECG Findings of Potential Clinical Concern ...................................88
10.9. Appendix 9: Prohibited Concomitant Medications That May Result in 
Drug-Drug Interaction (DDI) ....................................................................................90
10.10. Appendix 10: Child-Pugh Classification of Liver Dysfunction..........................92
10.11. Appendix 11: Abbreviations ...............................................................................93
11. REFERENCES ..................................................................................................................97
LIST OF TABLES
Table 1.
Study Schedule of Activities ....................................................................17
Table 2.
Completed PF-07923568 Studies .............................................................22
Table 3.
Hepatic Function Categories Based on Child-Pugh Score .......................27
Table 4.
Plasma PK Parameters..............................................................................60
Table 5.
Expected Widths of the 90% CIs (with 80% Coverage Probability) 
for Different Possible Estimated Effects ..................................................63
Table 6.
Protocol-Required Safety Laboratory Assessments .................................72
Table 7.
Scoring for Child-Pugh Classification10...................................................92
Table 8.
Derivation of Child-Pugh Classification Score ........................................92
Table 9.
Determination of Encephalopathy Grade .................................................92
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Protocol C5241012
Final Protocol, 23 February 2023
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1. PROTOCOL SUMMARY
1.1. Synopsis
Protocol Title:
A Phase 1, Open-Label, Single-Dose, Parallel Group Study to Compare the Pharmacokinetics 
of PF-07923568 in Adult Participants With Varying Degrees of Hepatic Impairment Relative 
to Participants Without Hepatic Impairment
Brief Title:
A Study to Investigate the Effects of Hepatic Impairment on the Pharmacokinetics of 
PF-07923568
Regulatory Agency Identification Number(s):
US IND Number:
143479
EudraCT/CTIS Number:
NA
ClinicalTrials.gov ID:
Not available
Pediatric Investigational Plan Number:
NA
Protocol Number:
C5241012
Phase:
1
Rationale:
The primary purpose of this study is to characterize the effect of varying degrees of HI on the 
plasma PK of PF-07923568 following administration of a single oral dose of PF-07923568.
Objectives and Endpoints:
Objectives
Endpoints
Primary:
Primary:
!
To compare the PK of PF-07923568 following administration 
of a single oral dose in adult participants with varying degrees 
of HI relative to age- and body weight-matched participants 
without HI.
!
Plasma: Cmax, AUClast or AUCinf*, as data 
permit.
Secondary:
Secondary:
!
To evaluate the safety and tolerability of a single oral dose of 
PF-07923568 when administered to adult participants with 
varying degrees of HI and in age- and body weight-matched 
participants without HI.
!
Assessment of TEAEs, clinical laboratory 
abnormalities, vital signs, ECG parameters.
* AUClast will be treated as primary endpoints if data do not permit robust estimation of AUCinf, otherwise they will be 
treated as tertiary endpoints.
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P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0
O ver all Desi g n :
T his is a n o pe n -la bel, si n gle-d ose, parallel -gr o u p , m ulti ce nter st u d y t o i n vesti gate t he effect 
of var y i n g de grees of he patic f u ncti o n o n t he plas ma P K of P F - 0 7 9 2 3 5 6 8 after a si n gle, oral 
m g d ose a d mi nistere d i n t he fe d state (sta n dar d brea kfast). Safety a n d t olera bilit y will be 
e val uate d t hr o u g h o ut t he st u d y .
N u m ber of P artici p a nts:
A p pr o xi matel y  2 8- 3 2 partici pa nts will be e nr olle d t o recei ve st u d y i nter ve nti o n.
N ote: " E nr olle d" mea ns a partici pa nt's, or t heir le gall y a ut h orize d re prese ntati ve’s, a gree me nt 
t o partici pate i n a clinical st u d y  f oll o wi n g c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d
assi g n me nt t o st u d y i nter ve nti o n. A partici pa nt will be c o nsi dere d e nr olle d if t he i nf or me d 
c o nse nt is n ot wit h dra w n pri or t o partici pati n g i n a n y  st u d y acti vit y after scree ni n g . P ote ntial 
partici pa nts w h o are scree ne d f or t he p ur p ose of deter mi ni n g eli gi bilit y  f or t he st u d y, b ut d o 
n ot partici pate i n t he st u d y, are n ot c o nsi dere d e nr olle d, u nless ot her wise s pecifie d b y t he 
pr ot oc ol.
St u d y P o p ul ati o n :
K e y  incl usi o n a n d e xcl usi o n cr iteria are liste d bel o w:
Ke y I ncl usi o n Criteri a
Partici pa nts m ust meet t he f oll o wi n g k e y  i ncl usi o n criteria t o be eli gi ble f or st u d y 
e nr oll me nt:
All Gr o u p s

Male s or fe males bet wee n t he a ges of 1 8 ( or t he mi ni m u m c o u ntr y -s pecific a ge of 
c o nse nt if > 1 8) a n d 7 5 ye ars, i ncl usi ve at t he scree ni n g visit .

Willi n g a n d a ble t o c o m pl y  wit h all sc he d ule d visits, treat me nt pla n, la b orat or y tests, 
lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.

B MI
of 1 7. 5 t o 3 8. 0 k g/ m 2, i ncl usi ve, a n d a t otal b o d y wei g ht > 5 0 k g ( 1 1 0 l b).

Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt .
A d diti o n al f or Gr o u p 1 O nly (wit h o ut HI )

At scree ni n g, n o cli nicall y  rele va nt a b n or malities i de ntifie d b y a detaile d me dical 
hist or y , c o m plete p h y sical e xa mi nati o n, i ncl u di n g B P a n d p ulse rate meas ure me nt, 
sta n dar d 1 2- lea d E C G a n d cli nical la b orat or y tests.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
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!
At screening, meet the demographic-matching criteria, including body weight within
±15 kg and age within ±10 years, of the average of the pooled hepatic impairment 
groups, as provided by the sponsor.
!
No known or suspected hepatic impairment and meet all the following criteria based 
on screening laboratory tests: ALT ≤ ULN, AST ≤ ULN, T bili ≤ULN, albumin 
≤ULN, and PT ≤ULN.
Additional for Groups 2-4 Only (Mild, Moderate, and Severe HI)
!
Stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh 
classification with no clinically significant change in disease status within 28 days 
before screening.
!
Stable concomitant medications for the management of individual participant’s 
medical history.
Key Exclusion Criteria
Participants with any of the following characteristics/conditions will be excluded:
All Groups
!
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, 
gastrectomy, ileal resection).
!
At screening, a positive result for HIV antibodies.
!
History of surgery that would be expected to alter absorption, distribution, 
metabolism, or excretion properties of PF-07923568 (eg, status post portacaval shunt 
surgery).
!
Other medical or psychiatric condition or laboratory abnormality that may increase 
the risk of study participation or make the participant inappropriate for the study.
!
Use of specific prohibited prior/concomitant therapies as outlined in the protocol
including use of an investigational product within 30 days (or local requirement) or 
5 half-lives (whichever longer), or 14 days plus 5 half-lives for moderate and strong 
CYP3A inducers or time-dependent inhibitors, before study dose.
!
eGFR <60 mL/min/1.73m2 (calculated with the 2021 CKD-EPI Scr-Scys combined 
equation) at screening.
!
A positive urine drug test at screening or Day -1; however, participants in 
Groups 2-4, only, who have been medically prescribed medications and report use at 
screening may be allowed after sponsor approval.
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!
At screening or Day -1, a positive breath alcohol test.
!
For females, pregnancy, as indicated by a positive serum pregnancy test at screening 
and/or positive urine pregnancy test in women of childbearing potential at Day -1.
Additional Group 1 Only (without HI)
!
Evidence of chronic liver disease including history of hepatitis, hepatitis B, or 
hepatitis C.
!
History of alcohol abuse or binge drinking and/or any other illicit drug use or 
dependence within 6 months of screening.
!
Screening supine standard 12-lead ECG demonstrating QTcF interval >450 ms or a 
QRS interval >120 ms.
!
Screening seated SBP ≥140 mmHg or DBP ≥90 mmHg, following ≥5 minutes of 
seated rest.
!
Use of chronic prescription medications within 7 days or 5 half-lives (whichever is 
longer) before Day 1, or for prohibited medications, use within the required 
washout/restriction period in the protocol.
Additional Exclusion Criteria for Groups 2-4 Only (Mild, Moderate, and Severe HI)
!
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy 
(defined as <1 year).
!
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular 
process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, 
CT scan, or MRI.
!
History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less 
than 4 weeks prior to screening.
!
Signs of clinically active Grade 3 or 4 hepatic encephalopathy (ie, > Grade 2 Portal 
Systemic Encephalopathy score).
!
Severe ascites and/or pleural effusion, except for those categorized in Group 4 who 
may be enrolled provided participant is medically stable, per the investigators’ 
medical judgment.
!
Previously received a kidney, liver, or heart transplant.
!
Screening supine 12-lead ECG demonstrating a QTcF interval >470 ms or a QRS 
interval >120 ms.
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P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3

At scree ni n g, Da y  - 1, or pre -d ose o n Da y  1, persiste nt se vere, u nc o ntr olle d 
h y perte nsi o n .

A L T or A S T > 5 x U L N o n cli nical la b orat or y  tests at scree ni n g.
St u d y Ar ms a n d D ur ati o n:
A t otal of a p pr o xi matel y  28- 3 2 partici pa nts wit h var y i n g de grees of he patic f u ncti o n will be 
a d mi nistere d a si n gle, oral
 m g d ose of P F- 0 7 9 2 3 5 6 8 i n t he fe d state as s h o w n i n t he ta ble
bel o w.
He p atic F u ncti o n C ate g ories B ase d o n C hil d -P u g h Sc ore
Gr o u p
Descri pti o n
C hil d -P u g h Sc ore
N u m ber of P artici p a nts
1
Wit h o ut he patic i m pair me nt
N ot A p plica ble
8 a
2
Mil d he patic
i mpair me nt
Class A ( 5 t o 6 p oi nts)
8
3
M o derate he patic i m pair me nt 
Class B ( 7 t o 9 p oi nts)
8
4
Se ver e he patic i m pair me nt
Class C ( 1 0 t o 1 5 p oi nts)
4- 8 b
a.
A d diti o nal partici pa nts ma y be d ose d t o a ma xi m u m of 1 0 partici pa nts t o e ns ure mea n a ge ± 1 0 years a n d 
mea n b o d y wei g ht ± 1 5 k g of t his gr o u p is ali g ne d wit h t he p o ole d a vera ge assesse d w he n a p pr o xi matel y 
≥7 5 % of partici pa nts are d ose d acr oss t he ot her 3 gr o u p s.
b.
T he t otal n u m ber of partici pa nts e nr olle d t hat are classifie d as ha vi n g se vere HI will be a mi ni m u m of 4 
t o a ma xi m u m of 8 de pe n di n g o n recr uit me nt rates.
Cate g orizati o n of partici pa nts i nt o Gr o u p s 2- 4 will be d o ne base d o n C hil d -P u g h sc ores 
deter mi ne d at t he scree ni n g visit.
St a ge d E nr oll me nt of St u d y Gr o u ps
Partici pa nts will be d ose d i n a sta ge d ma n ner as f oll o ws:

Partici pa nts wit h m o derate HI ( Gr o u p 3) a n d se vere HI ( Gr o u p 4) will be e nr olle d 
first.

Recr uit me nt of partici pa nts wit h mil d HI ( Gr o u p 2) will i nitiate w he n 
a p pr o xi matel y 5 0 % of t he partici pa nts i n G r o u p 3 ha ve bee n d ose d.

S p o ns or a p pr ov al is re q uire d bef ore pr ocee di n g wit h recr uit me nt of Gr o u p 2.

A n a vera ge val ue f or a ge a n d wei g ht f or t he 3 HI gr o u ps ( Gr o u ps 2- 4 ) will be 
deter mi ne d a n d partici pa nts wit h o ut H I (Gr o u p 1) will be recr uite d t o matc h t he 
a vera ge de m o gra p hics (at a mi ni m u m, a ge a n d wei g ht, a n d as m uc h as practicall y  
p ossi ble ge n der) acr oss t he p o ole d Gr o u ps 2- 4.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4

R ecr uit me nt f or healt h y partici pa nts i n Gr o u p 1 ( wit h o ut HI ) m a y  start w he n 
a p pr o xi matel y 7 5 % of t otal partici pa nts acr oss Gr o u ps 2- 4 (ie, a p pr o xi matel y 1 5
t o 1 8 partici pa nts) ha ve bee n d ose d.

S p o ns or a p pr ov al is re q uire d bef ore pr ocee di n g wit h recr uit m e nt of Gr o u p 1.
F or i n di vi d ual partici pa nts, t he t otal d urati o n of partici pati o n fr o m t he scree ni n g visit t o t he 
f oll o w-u p visit will ra n ge fr o m a p pr o xi matel y  5 wee ks ( mi ni m u m) t o a p pr o xi matel y 8 wee ks 
( ma xi m u m). T he st u d y  c o nsists of a n i nitial scree ni n g peri o d of u p t o 2 8 da y s ( w hile 
all o wi n g f or t he ret ur n a n d re vie w of all res ults, i ncl u di n g la b orat or y  tests), a 6- d a y  i n patie nt 
sta y at t he C R U w hic h i ncl u des a d mi nistrati o n of a si n gle oral d ose of P F-0 7 9 2 3 5 6 8 , a n d a 
f oll o w-u p c o ntact t hat will occ ur 2 8 -3 5 da y s after P F-0 7 9 2 3 5 6 8 a d mi nistrati o n.
P F -0 7 9 2 3 5 6 8 will be s u p plie d b y  Pfizer as
m g  ca ps ules i n o pe n-la bel b ul k b ottles al o n g 
wit h i n di vi d ual d osi n g c o ntai ners, as necessar y , f or u nit d osi n g. F or t he 
m g d ose 
a d mi nistere d i n t his st u d y, partici pa nts will ta ke 4 P F - 0 7 9 2 3 5 6 8
m g ca ps ules orall y wit h 
t he m or ni n g meal.
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F -0 7 9 2 3 5 6 8
Ar m N a me
( gr o u p of p artici p a nts recei vi n g a 
s pecific tre atme nt or n o tre at me nt)
Gr o u p 1, Gr o u p 2, Gr o u p 3 , Gr o u p 4
U nit D ose Stre n gt h(s)
m g
R o ute of A d mi nistr ati o n
Oral
Use
E x peri me ntal
I M P or NI M P/ A x M P
I M P
A r m  Title
Gr o u p 1
Gr o u p 2
Gr o u p 3
Gr o u p 4
A r m  T y pe
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal
A r m  
Descri pti o n
Partici pa nts wit h o ut 
HI will recei ve a 
si n gle
m g d ose 
of P F -0 7 9 2 3 5 6 8
a d mi nistere d orall y 
as 4 P F -0 7 9 2 3 5 6 8
m g ca ps ule s
Partici pa nts wit h 
mil d HI will recei ve 
a si n gle
m g d ose 
of P F -0 7 9 2 3 5 6 8 
a d mi nistere d orall y 
as 4 P F -0 7 9 2 3 5 6 8 
m g ca ps ule s
Partici pa nts wit h 
m o derate HI will 
recei ve a si n gle
m g d ose of 
P F -0 7 9 2 3 5 6 8 
a d mi nistere d orall y 
as 4 P F -0 7 9 2 3 5 6 8 
m g ca ps ule s
Partici pa nts wit h 
se vere HI will 
recei ve a si n gle
m g d ose of 
P F -0 7 9 2 3 5 6 8 
a d mi nistere d orall y 
as 4 P F -0 7 9 2 3 5 6 8 
m g ca ps ules
St atistic al Met h o ds :
A sa m ple size of a p pr o xi matel y  28- 3 2 partici pa nts (a p pr o xi matel y  8 partici pa nts per G r o u ps
1- 3, a n d 4-8 partici pa nts i n Gr o u p 4 base d o n recr uit me nt rate , wit h var yi n g de grees of 
he patic f u ncti o n i n eac h of t he 4 gr o u ps) has bee n selecte d base d o n rec o m me n dati o n fr o m 
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 15
the “FDA Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic 
Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”.1 Participants 
who discontinue from the study before completing all assessments may be replaced at the 
discretion of the investigator and sponsor.
The effect of varying degrees of HI on PK parameters will be assessed by constructing 90% 
CI around the estimated difference between each of the Test (hepatic impaired) groups and 
the Reference (without hepatic impairment) group. A one-way ANOVA will be used to 
compare the natural log transformed PF-07923568 AUCinf, Cmax, and AUClast, as data permit, 
for each of the hepatic impairment groups (Test) to the group without hepatic impairment 
(Reference). Estimates of the adjusted mean differences (Test /Reference), and corresponding 
90% CIs, will be obtained from the model. These will be exponentiated to provide estimates 
of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
All safety analyses will be performed on the safety population. AEs, ECGs, BP, pulse rate, 
and safety laboratory data will be reviewed and summarized on an ongoing basis during the 
study to evaluate the safety of participants. Any clinical laboratory, ECG, BP, and pulse rate 
abnormalities of potential clinical concern will be described. Safety data will be presented in 
tabular and/or graphical format and summarized descriptively, where appropriate following 
Sponsor standards.
Ethical Considerations:
A single dose of PF-07923568 administered in this study is not expected to provide any 
clinical benefit to study participants. This study is designed primarily to characterize the 
effect of varying degrees of HI on the PK of PF-07923568. Results from this study will be 
used in conjunction with collective safety, tolerability, efficacy, and PK/PD data from other 
PF-07923568 studies to develop dosing recommendations for the target patient populations 
with varying degrees of hepatic function.
1.2. Schema
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 16
1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the 
STUDY ASSESSMENTS AND PROCEDURES section of the protocol for detailed 
information on each procedure and assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA
table, in order to conduct evaluations or assessments required to protect the well-being of the 
participant.
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 17
Table 1.
Study Schedule of Activities
Visit Identifier/Day
[list of abbreviations in Appendix 11]
Screen
≤-28 to
-2
Day 
-1
Day 1
Day 2
Day 3 Day 4 Day 5
Day 6
ET
Follow-upa
Day 29-36
Hours Post Dose
--
0
1
2
3
4
5
6
8
10 12 14
24
48
72
96
120
--
--
Informed consent & demography
x
Outpatient visit
x
Inpatient stay at CRU
x
∀∀∀∀∀∀∀∀∀∀∀
∀
∀
∀
∀
x
COVID-19 assessmentb
Eligibility assessment
x
x
x
Medical history
x
Child-Pugh Classification scoring
x
PE (height & weight at screening 
only)c
x
x
x
x
Breath alcohol & Urine drug test
x
x
Alcohol/tobacco & contraception used
x
x
x
x
x
(Update) Prior/concomitant 
treatments
x
x
∀∀∀∀∀∀∀∀∀∀∀
∀
∀
∀
∀
x
x
x
Single, supine 12-lead ECGe
x
x
xe
x
x
x
Single, seated vital signs (BP, pulse 
rate)e
x
x
xe
x
x
x
AE monitoring (non-serious & SAEs)
x
∀
∀∀∀∀∀∀∀∀∀∀∀
∀
∀
∀
∀
x
x
x
Standard meals/optional snacksf
xf
x
x
x
x
x
x
x
x
x
Study intervention administrationg
x
Blood & Urine for clinical laboratory 
testsh
x
xj
x
x
Serology for FSH (all females), HIV, 
HBsAg, HCVAb/RNA
x
Serum pregnancy test (all females)
x
Urine pregnancy test (WOCBP only)i
x
x
x
Blood for PK sampling for 
PF-07923568 and Blood:Plasma
xj
x
x
x
x
xk
x
x
xk
x
x
x
x
x
x
Retained Research Sample for 
Genetics (Prep D1)l
xj
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 18
Table 1.
Study Schedule of Activities
Visit Identifier/Day
[list of abbreviations in Appendix 11]
Screen
≤-28 to
-2
Day 
-1
Day 1
Day 2
Day 3 Day 4 Day 5
Day 6
ET
Follow-upa
Day 29-36
Hours Post Dose
--
0
1
2
3
4
5
6
8
10 12 14
24
48
72
96
120
--
--
Retained Research Sample for 
Biomarkers (Prep B2)m
xj
a.
Follow-up visit to be performed as telephone contact and must occur in the window of 28 to 35 days (ie, Day 29-36) from administration of study intervention. A clinic visit 
may be performed in place of telephone contact, if deemed necessary by the investigator, eg, for follow-up of abnormal laboratory tests and/or open AEs.
b.
Assessment of risk for, symptoms of or testing for COVID-19 may be performed at screening, admission to the CRU, and/or at other times during the study at investigator 
discretion and according to local site policies.
c.
Complete PE at screening; at all other time points limited PE, at investigator discretion (see Section 8.3.1).
d.
In confirmation of appropriate contraception use only.
e.
If done around the time of a blood draw, ECG and vital sign assessments (BP and pulse rate) should be collected before the blood draw. ECG and vital signs on Day 1 at 
Time 0H must be done before collection of the pre-dose blood samples. If an IV catheter is utilized for blood sample collections, ECGs and vital sign assessments (BP and 
pulse rate) should be collected before insertion of the catheter.
f.
Meals/snacks to be served at clock times matching approximately 0H, 4H, 6H (optional snack), 10H, and 14H (optional snack) relative to dosing on Day 1, while inpatient. 
Meals/snacks on Day -1 must be timed such that there is at least an 8 hour fast prior to collection of the pre-dose PK sample on Day 1 (see Section 5.3.2).
g.
Dosing to occur with standard morning meal provided approximately 30 minutes prior to 0H, and meal completed approximately 10 minutes prior to dosing.
h.
Safety related laboratory tests collected on Day -1, if performed at investigator discretion, must be reviewed prior to dosing and must reflect the participant to be in stable 
medical condition.
i.
Test result must be reviewed and deemed acceptable (ie, negative) to continue participation in the study.
j.
Samples at 0H on Day 1 must be collected pre-dose.
k.
Whole blood aliquot (approximately 0.15 mL) will be collected from PK samples for in vivo blood:plasma ratio assessment.
l.
Prep D1 Retained Research Samples for Genetics: If not collected on the designated collection day, collect at the next available time point when biospecimens are being 
collected in conjunction with a participant visit.
m.
Prep B2 Retained Research Samples for Biomarkers: If not collected on the designated collection day, collect at the next available time point when biospecimens are being 
collected in conjunction with a participant visit.
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 9
2. I N T R O D U C TI O N
P F - 0 7 9 2 3 5 6 8 (sis u nat o vir) is bei n g de vel o pe d t o act as a hi g hl y  p ote nt, selecti ve, orally 
a vaila ble a ge nt t o treat a n d pre ve nt R S V i nfecti o n. P F - 0 7 9 2 3 5 6 8 is a n i n hi bit or of 
 
 t hat is c urre ntly bei n g i n vesti gate d f or t he treat me nt of 
R S V i nfecti o n.
2. 1. St u d y R ati o n ale
T he pri mar y  p ur p ose of t his st u d y is t o c haracterize t he effect of var yi n g de grees of HI o n t he 
plas ma P K of P F- 0 7 9 2 3 5 6 8 f oll o wi n g ad mi nistrati o n of a si n gle oral d ose of P F -0 7 9 2 3 5 6 8 .
2. 2. B ac k gr o u n d
R S V, a me m ber of t he P ne u m o vir us fa mil y , is a si g nifica nt pat h o ge n of t he ver y yo u n g, 
i m m u n oc o m pr o mise d, a n d t he el derl y. R S V is u bi q uit o us a n d is k n o w n t o i nfect al m ost all 
c hil dre n b y 2 years of a ge.2 T h e cli nical ma nifestati o n of R S V i nfecti o n is t y picall y mil d 
u p per res pirat or y  tract ill ness.3 H o we ve r, i n i nfa nts, yo u n g c hil dre n, t he 
i m m u n oc o m pr o mise d, a n d t he el derl y, it ca n ca use seri o us L R TI .4 I nfa nts < 6 m o nt hs of a ge 
are at t he hi g hest ris k of se vere R S V i nfecti o n w hic h ca n lea d t o h os pitalizati o n, I CU 
a d missi o n , a n d e ve n deat h .5
T he c urre nt ma na ge me nt of R S V i nfecti o n i ncl u des a c o m bi nati o n of pre ve ntati ve a n d 
li mite d treat me nt meas ures, pri maril y c o nsisti n g of s u p p orti ve care. Ri ba viri n, a n ucle osi de 
a nal o g ue, is c urre n tl y t he o nl y lice nse d a nti viral f or t he treat me nt of R S V i n c hil dre n 
( Viraz ole® ).6 T here is n o a p pr o ve d a nti viral f or t he treat me nt of R S V i n ot her a ge gr o u p s. 
M ost c urre nt g ui deli nes ma ke eit her n o rec o m me n dati o n or d o n ot rec o m me n d r o uti ne use of 
ri ba viri n d ue t o its wea k a nti viral ca pacit y, i n here nt t o xicit y a n d terat o ge nic p ote ntial.7 T h us, 
a place b o -c o ntr olle d desi g n is c o nsi dere d a p pr o priate f or trials of ne w a nti viral a ge nts f or t he 
treat me nt of R S V. Pali viz u ma b ( S yna gis ® ) is a pr o p h ylactic m o n ocl o nal a nti b o d y t hat has 
bee n s h o w n t o pr otect i nfa nts a gai nst R S V disease a n d is use d i n s pecifie d hi g h ris k i nfa nt 
gr o u ps. Des pite t he a vaila bilit y  of t hese a ge nts, t heir li mite d use mea ns t hat treat me nt of 
R S V i nfecti o n re mai ns a n area of u n met nee d.
P F - 0 7 9 2 3 5 6 8 is a p ote nt i n hi bit or of 
 T he R S V 
F pr otei n is esse ntial f or t he e ntr y of t he vir us t o t he h ost cell. Cell s urface e x pressi o n of t he 
F pr otei n als o ca uses 
 lea di n g t o t he gia nt sy nc yt ia c haracteristic of R S V 
i nfecti o n.
T he P F - 0 7 9 2 3 5 6 8 precli nical pr ofile, as well as t he safet y a n d t olera bilit y data fr o m t he first 
h u ma n d osi n g st u dies, pr o vi de a str o n g rati o nale f or t he cli nical de vel o p me nt of 
P F -0 7 9 2 3 5 6 8.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI
C CI


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 0
2. 2. 1. N o ncli nic al P h ar m ac ol o g y
 
 
 
 
A n i n vitr o sec o n dar y p har mac ol o g y  st u d y di d n ot re veal a ny 
si g nifica nt off-tar get acti vit y f or P F - 0 7 9 2 3 5 6 8.
Details of t he n o ncli nical p har mac ol o g y  pr o gra m are i ncl u de d i n t he I B w hic h is t he S R S D
f or t his st u d y.
2. 2. 2. N o ncli nic al P h ar m ac o ki netics a n d Met a b olis m
I n a ni mal P K st u dies, P F -0 7 9 2 3 5 6 8 s h o we d sl o w oral a bs or pti o n, m o derate- hi g h C L, hi g h 
v ol u me of distri b uti o n, a n d oral bi oa vaila bilit y  of 4 6 %, 4 2-1 3 2 %, a n d 4 4 % i n m o use, rat, a n d 
d o g, res pecti vel y.
Plas ma pr otei n bi n di n g of P F - 0 7 9 2 3 5 6 8 was l o w t o m o derate acr oss s pecies, wit h a vera ge 
fracti o n u n b o u n d of 6 7 %, 3 8 %, 5 2 %, 2 7 %, a n d 4 8 % i n h u ma n, m o use, rat, d o g , a n d g ui nea 
pi g, res pecti vel y. Re peat d osi n g st u dies i n t he rat s h o w t hat e xte nsi ve distri b uti o n of 
P F - 0 7 9 2 3 5 6 8 t o t he l u n gs occ urs, res ulti n g i n hi g h l u n g-t o-plas ma rati o. T his effect is greater 
t ha n d ose pr o p orti o nal fr o m 5 0 m g/ k g t o 1 5 0 m g/ k g.
C o nsiste nt wit h t he res ults of t he mi daz ola m D DI  st u d y ( C 5 2 4 1 0 0 4), i n vitr o st u dies i n dicate
t hat C Y P 3 A 4 is t he mai n C Y P is of or m t hat meta b olizes P F - 0 7 9 2 3 5 6 8 wit h mi n or 
c o ntri b uti o n fr o m C Y Ps 2 C 9 a n d 2 D 6.
I n vitr o st u dies i n dicate a D DI ris k e xists f or O A T P 1 B 1/ 1 B 3, O C T 1, M A T E 1, O C T 2, a n d 
O A T 3. H o we ver, rati os of u n b o u n d he patic i nlet c o nce ntrati o ns relati ve t o Ki val ues are l o w, 
a n d D DI ris k is c o nsi dere d u nli kel y  f or O A T Ps, O C T 2, a n d O A T 3. 
A d diti o nall y , i n vitr o st u dies i n dicate t here is a ris k of i n hi biti o n of C Y Ps 1 A 2, 2 B 6, 2 C 9, 
2 C 1 9, a n d 3 A 4. T he D DI wit h C Y Ps 1 A 2, 2 C 9, a n d 2 C 1 9 is pre dicte d t o be mi ni mal 
( pre dicte d less t ha n 2 5 % i ncrease i n A U C of a se nsiti ve s u bstrate) a n d D DI wit h C Y P 2 B 6 is 
pre dicte d t o be wea k. A D DI st u d y  c o n d ucte d wit h sis u nat o vir (
 a n d
as a se nsiti ve 
pr o be s u bstrate ( C 5 2 4 1 0 0 4) i n dicate t hat sis u nat o vir is  
 
I n vitr o st u dies i n dicate t hat sis u nat o vir is a P- gp s u bstrate; t heref ore, c o -a d mi nistrati o n of 
i n hi bit ors f or t he tra ns p orter ( P-g p) ma y  res ult i n i ncrease d e x p os ure t o sis u nat o vir 
(a p pr o xi matel y 2-f ol d). A cli nical D DI st u dy ( C 5 2 4 1 0 0 4) i n dicate d t hat 
 
 c oa d mi nistratio n pr o d uce d a n a p pr o xi matel y 
 i n 
e x p os ure t o sis u nat o vir. 
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 21
The major metabolites produced in all species appeared to be hydroxylated metabolites 
although some Phase 2 metabolites were also detected in all species. The metabolite profile 
in the rat, mouse, dog, guinea pig, and human were similar with the exception of M4, an 
apparent double hydroxylation only apparent in human at low levels.
Further details of the nonclinical PK and metabolism program are included in the IB.
2.2.3. Nonclinical Safety
In the repeat dose toxicity studies in adult (up to 28 days) and neonatal/juvenile rats and 
dogs, the MTDs were defined by body weight loss and reduced food consumption 
accompanied by adverse clinical observation of varying severity. In dogs, there was dose-
related incidence of emesis and liquid feces at ≥15 mg/kg/day. The key target organ for 
toxicity in adult animals was the hepatobiliary system, which included both degenerative and 
inflammatory changes in bile duct, in rats (≥60 mg/kg/day) and dogs (≥45 mg/kg/day). In 
dogs, the hepatobiliary findings correlated with elevated plasma levels of ALP, ALT, and 
GGT. In addition, the findings observed only in rats were in kidney 
(degeneration/regeneration of medullary tubules) at ≥120 mg/kg/day, lung (vascular 
degeneration/necrosis) at 240 mg/kg/day (non-tolerated dose), and trachea (epithelial 
degeneration and subepithelial inflammation [predominantly in females]) at 120 mg/kg/day 
in 14 and/or 28-day studies. In the 28-day dog repeat dose toxicity study, the NOAEL was 15 
mg/kg/day corresponding to Cmax of 729 ng/mL and AUCtau of 9510 ng.h/mL. In the 28-day 
rat repeat dose toxicity study, the NOAEL was 60 mg/kg/day corresponding to Cmax of 322 
ng/mL and AUCtau of 4725 ng.h/mL.
In the embryo-fetal toxicity studies in rat (GD6-17) and rabbit (GD6-18), there were no 
effects on pregnancy or embryo-fetal development. In rat, the NOAEL for maternal toxicity 
was 45 mg/kg/day based on the transient initial body weight loss followed by dose-related 
decreased body weight gain at ≥45 mg/kg/day. The NOAEL for embryo-fetal toxicity in rat 
was 60 mg/kg/day, corresponding to systemic maternal exposure (AUC24) of 9830 ng.h/mL 
on Day 15 of gestation. In rabbit, maternal toxicity was limited to lower body weight gain 
and food intake at 45 mg/kg/day. The NOAEL for embryo-fetal development in rabbit was 
45 mg/kg/day, corresponding to a systemic maternal exposure (AUC24) of 220 ng.h/mL on 
Day 16 of gestation.
Further details of the nonclinical toxicology program are included in the IB.
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Protocol C5241012
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2.2.4. Clinical Overview
Table 2.
Completed PF-07923568 Studies
Study Number
(Status)
Study Type/Key 
Design Features
Study Population
Dose, Dosing 
Regimen
Formulation Used
C5241001-
previously 
REVC001a
(completed)
Phase 1, 
randomised, 
double-blind, 
placebo-controlled, 
safety, tolerability, 
PK, food-effect of 
single ascending 
dose (SAD) and 
multiple ascending 
dose (MAD)
Healthy participants
Dose range: 10 mg –
525 mg (SAD); 
36 participants
Dose range: 175 mg 
– 350 mg; BID 
(MAD), food effect; 
24 participants
Liquid Formulation
DIC
C5241002-
previously 
REVC002
(completed)
Phase 2a, 
randomised, 
double-blind, 
placebo-controlled
Healthy participants 
inoculated with RSV 
CV
200 mg or 350 mg
BID for a total 
10 doses; 
66 participants
DIC
C5241004-
previously 
REVC004
(completed)
Phase 1, adaptive, 
part-randomised, 
part open-label, drug 
interactions, safety
and tolerability
Healthy participants
200 mg; BID; 
62 participants
DIC
C5241005-
previously 
REVC005
(completed)
Phase 1, open-label, 
single-dose, PK, 
safety, and 
tolerability
Healthy participants
200 mg, 4 single 
doses total; 
9 participants
1 ×: DIC (fed)
1 ×: DPB (fed)
1 ×: DPB dispersed 
in H2O (fed)
1 ×: DPB dispersed 
in H2O (fasted)
[wash-out: 3 days 
between each of the 
4 dosing days]
DIC
DPB
a.
A total of 8 participants received the liquid dosage formulation of PF-07923568 in a solution, at a 
concentration of 5 mg/mL, containing hydroxypropyl-β-cyclodextrin (HBP cyclodextrin), Lycasin, 
flavoring agent (strawberry) benzoic acid and water, and 68 subjects received DIC in the study.
Abbreviations: BID = twice-daily dosing; DIC = PF-07923568 drug in capsule; DPB = PF-07923568 dry 
powder blend; MAD = multiple ascending dose; PK = pharmacokinetic; RSV = respiratory syncytial virus; 
RSV CV = RSV challenge virus; SAD = single ascending dose.
A total of 201 adult healthy participants have received PF-07923568 in 4 completed clinical 
studies (C5241001, C5241002, C5241004, and C5241005) investigating the PK profile, 
effects of food on PK, effects of formulation on PK (C5241001, C5241005), DDIs 
(C5241004), and the efficacy in an RSV Viral Challenge Study (C5241002) at doses ranging 
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Protocol C5241012
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from 10 mg to 525 mg. In addition, as of 14 November 2022, 49 pediatric patients 
hospitalized due to RSV LRTI have been enrolled into the ongoing C5241003 study.
The administration of PF-07923568 was well tolerated at all doses, dosage forms, and dosing 
regimens tested. In the adult healthy participants treated to date, the occurrence of TEAEs 
considered related to PF-07923568 has been low. Most commonly reported treatment-related 
TEAEs were in the GI disorders SOC; nausea, diarrhea, and abdominal pain. These TEAEs 
have been mild to moderate in intensity and resolved without sequelae. Most events 
attributed to IMP involved the GI tract with nausea, diarrhea, and abdominal 
pain/discomfort/distension being the most common and occurring more commonly with the 
350 mg dose of PF-07923568 than with the 200 mg PF-07923568 dose, where the number of 
participants reporting these events were lower and similar to those on placebo. In children, 
PF-07923568 is required to be suspended in a solution to enable oral administration, there 
has been evidence of poor tolerability when PF-07923568 was suspended in water as a single
dose of 2.0 mg/kg in children aged 6-36 months, resulting in expulsion of the oral dose. 
Suspension in breast milk, formula milk, or saline appeared to improve the palatability, with 
all doses being successfully administered to children aged 1-36 months in study C5241003.
As of 22 November 2022, there have been no SAEs attributable to PF-07923568 and no 
deaths in the clinical studies.
In adults, under both fasting and fed conditions, PF-07923568 is slowly absorbed reaching 
maximum plasma concentrations (tmax) at 5-6 hours (hrs) with a relatively moderate 
clearance, resulting in a half-life of 7-10 hrs in healthy participants. Dosing to steady state 
resulted in steady state concentrations being reached after approximately 2 days of dosing 
resulting in 2-4 fold accumulation of exposure. AUC and Cmax values increased in a greater 
than dose proportional manner across single and multiple dose studies. Following 5 days of 
dosing, the variability in PK parameters was high, with % CV ranging from 67.4-84% for 
Cmax and 71.9-144% for AUC12.
The effect of food on the single dose PK was assessed for the DIC formulation and DPB 
formulation dispersed in water. For the DIC the extent of systemic exposure to PF-07923568
(geometric mean AUCinf under fed and fasted conditions) was 357 and 221 ng.h/mL,
respectively, with the between-subject variability being lower under fed conditions (CV 
64.1% compared with 198%). The ratio of fed/fasted was 218% (90% CI 94.2 - 502%) for 
Cmax and 162% (90% CI 83.0 – 316%) for AUC0-inf. It should be noted that the DIC fasted 
results from C5241001 were lower than typically seen in other studies with 200 mg 
administered under fasting conditions resulting in an artificially higher ratio of fed/fasted in 
this study. For the DPB dispersed in water the extent of systemic exposure to PF-07923568
(geometric mean AUCinf) under fed and fasted conditions was 371 and 337 ng.h/mL,
respectively, with the between-subject variability being slightly lower under fasted 
conditions (CV 49.0% compared with 61.6%). The ratio of fed/fasted was 107.7% (90% CI 
78.0 – 148.8%) for Cmax and 110.0% (90% CI 85.6 – 141.4%) for AUCinf. 
Clinical DDI Study C5241004 demonstrated that the disposition of PF-07923568 is expected 
to be affected by moderate to strong inhibitors and inducers of CYP3A4. Furthermore, 
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Protocol C5241012
Final Protocol, 23 February 2023
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PF-07923568 was demonstrated to be a moderate inhibitor of CYP3A4, so dose adjustments 
for compounds that are sensitive substrates for CYP3A4 may need to be considered.
In an RSV challenge study, PF-07923568 treatment resulted in a statistically significant 
reduction in AUC of RSV viral load compared with placebo; 55.25% (p=0.007) and 
63.05% (p=0.002) for the 200 mg and 350 mg PF-07923568 dose groups, respectively (dosed 
every 12 hrs [Q12H] for 5 days). Results for the AUC of total symptom score were consistent 
with the viral load AUC. Geometric mean AUCs of total symptom score were 195.56, 30.79,
and 31.76 hrs for placebo, 200 mg PF-07923568 and 350 mg PF-07923568, respectively. The 
reduction in AUCs of total symptom score compared with placebo was statistically 
significant for both PF-07923568 treatment groups; p=0.009 (70.84%) and p=0.002 
(74.42%), (Wilcoxon Rank-Sum test) for the 200 mg and 350 mg PF-07923568 dose groups, 
respectively.
More detailed information about results of clinical studies for PF-07923568 may be found in 
the IB.
2.3. Benefit/Risk Assessment
PF-07923568 is not expected to provide any clinical benefit to healthy participants. This 
study is designed primarily to generate safety, tolerability, and PK data for further clinical 
development.
For healthy participants participating in this study, no clinical benefit is expected. The 
purpose of the study is to provide the basis for further clinical development of PF-07923568 
as a potential new, pharmacological agent for the treatment of RSV. As of 14 September 
2022, no specific human risks have been identified; postulated risks based on nonclinical 
studies are summarized in Section 2.2.3. The clinical impact of these potential risks will be 
minimized through standard, intensive, inpatient monitoring of the participants following 
administration of multiple oral doses of the study intervention.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of sisunatovir may be found in the IB, which is the SRSD for this study.
2.3.1. Risk Assessment
Potential Risk 
of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention PF-07923568
Hepatobiliary 
system effects
Degenerative and inflammatory changes in the 
bile duct of both rats (≥60 mg/kg/day) and dogs 
(≥45 mg/kg/day) in studies of up to 28 days, 
with elevated plasma levels of ALP, ALT, and 
GGT in dogs only. Evidence of recovery for all 
findings following a 14-day treatment-free 
period.
Standard monitoring including 
laboratory (ie, transaminases, ALP, 
GGT) and AE monitoring.
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Protocol C5241012
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Potential Risk 
of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Gastrointestinal 
effects
Transient dose-related incidence of emesis and 
liquid feces in dogs at doses ≥15 mg/kg/day in 
studies up to 28 days. Additionally, 
inflammation in the duodenum, gall bladder, 
and liver at 45 mg/kg/day noted in 28-day dog 
study.
In previous clinical studies sisunatovir has been 
associated with mild GI AEs in fasted state.
As this is an investigational agent, there 
is some risk that is mitigated by close 
observation of AEs, etc. Participants 
will be closely evaluated in an inpatient 
setting to monitor for GI AEs. If 
needed, palliative alleviating measures 
such as antiemetics may be provided.
Renal effects
Degeneration/regeneration of medullary tubules 
was noted in rats at ≥120 mg/kg/day in studies 
of up to 28 days; considered non-adverse based 
on lack of clinical pathology changes.
Standard monitoring including 
laboratory and AE monitoring.
Cardiovascular 
effects
Myocardial degeneration and necrosis were
noted at 240 mg/kg/day (non-tolerated dose) in 
a 14-day rat study.
No similar effect in rats at 120 mg/kg/day in 
the 28-day study, or in dogs at any dose, for 
14 or 28 days.
Phase 1 first-in-human (FIH) study (C5241001) 
showed no adverse clinically significant 
changes in safety laboratory parameters 
(including troponin), ECGs, and VS.
Monitoring will include VS, including 
heart rate and ECG assessments.
Pulmonary
effects
Vascular degeneration/necrosis in lung at 240 
mg/kg/day and epithelial degeneration/necrosis 
in trachea at 120 mg/kg/day in 14-day rat study.
No similar effect in rats at 120 mg/kg/day in 
the 28-day study, or in dogs at any dose, for 14 
or 28 days.
Phase 1 FIH study (C5241001) showed no 
adverse clinically significant changes in safety 
laboratory parameters (including troponin), 
ECGs, and VS.
There will be standard safety 
monitoring including VS and AEs. 
Thymus effects
Lymphoid atrophy and decreased thymus 
weight and reduced size of thymus in both rats 
(≥120 mg/kg/day) and dogs ≥15 mg/kg/day) in 
studies of up to 28 days.
Evidence of recovery following a 14-day 
treatment-free period.
These findings are secondary to stress and not 
directly sisunatovir-related.
Standard monitoring including 
laboratory (ie, complete blood count 
with differential) and AE monitoring. 
Single dose regimen should further 
limit this potential risk.
Other
Risk of 
COVID-19 
exposure during 
study
During the pandemic, study participants could 
be exposed to the SARS-CoV-2 virus during 
study participation. This could lead to increased 
health risk for this participant and others in the 
study.
Assessment of risk for, symptoms of,
or testing for COVID-19 may be 
performed at screening, admission to 
the CRU, and/or at other times during 
the study at investigator discretion and 
according to local site policies.
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Protocol C5241012
Final Protocol, 23 February 2023
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2.3.2. Benefit Assessment
A single dose of PF-07923568 is not expected to provide any clinical benefit to study 
participants. This study is designed primarily to characterize the effect of varying degrees of 
hepatic impairment on the PK of PF-07923568 to support further clinical development of 
PF-07923568 as a potential treatment of RSV. Results from this study will be used in 
conjunction with collective safety, tolerability, efficacy, and PK/PD data from other 
PF-07923568 studies to develop dosing recommendations for the target patient population 
with varying degrees of hepatic function.
2.3.3. Overall Benefit/Risk Conclusion
PF-07923568 is not expected to provide any clinical benefit to healthy participants in this 
study.
Based on the profile of PF-07923568 observed in nonclinical and clinical studies to date, and 
taking into account the measures to minimize risk to study participants, the potential risk to 
the participants in this study is deemed to be minimal and is justified by the anticipated 
benefits that may be afforded to patients with varying degrees of HI receiving PF-07923568
in the future.
3. OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary:
Primary:
!
To compare the PK of PF-07923568 following administration 
of a single oral dose in adult participants with varying degrees 
of HI relative to age- and body weight-matched participants 
without HI.
!
Plasma: Cmax, AUClast or AUCinf*, as data 
permit.
Secondary:
Secondary:
!
To evaluate the safety and tolerability of a single oral dose of 
PF-07923568 when administered to adult participants with 
varying degrees of HI and in age- and body weight-matched 
participants without HI.
!
Assessment of TEAEs, clinical laboratory 
abnormalities, VS, ECG parameters.
Tertiary/Exploratory:
Tertiary/Exploratory:
!
To compare additional PK parameters of PF-07923568 
following administration of a single oral dose in adult 
participants with varying degrees of HI and in age- and body 
weight-matched participants without HI.
!
Plasma: CL/F, Vz/F, Tmax and t1/2 as data permit.
* AUClast will be treated as primary endpoints if data do not permit robust estimation of AUCinf, otherwise they will be 
treated as tertiary endpoints.
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 7
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
T his is a n o pe n -la bel, si n gle-d ose, parallel -gr o u p , m ulti ce nter st u d y t o i n vesti gate t he effect 
of var y i n g de grees of he patic f u ncti o n o n t he plas ma P K of P F- 0 7 9 2 3 5 6 8 after a si n gle, oral
m g d ose a d mi nistere d i n t he fe d state (sta n dar d brea kfast). Safet y a n d t olera bilit y will be 
e val uate d t hr o u g h o ut t he st u d y . A t otal of a p pr o xi matel y  28 - 3 2 partici pa nts wit h var y i n g 
de grees of he patic f u ncti o n will be a d mi nistere d as a si n gle, oral  
 m g d ose of 
P F -0 7 9 2 3 5 6 8 i n t he fe d state as s h o w n i n Ta ble 3.
T a ble 3.
He p atic F u ncti o n C ate g ories B ase d o n C hil d -P u g h Sc ore
Gr o u p
Descri pti o n
C hil d -P u g h Sc ore
N u m ber of 
P artici p a nts
1  
Wit h o ut HI
N ot A p plica ble
8 a
2
Mil d HI
Class A ( 5 t o 6 p oi nts)
8
3
M o derate HI
Class B ( 7 t o 9 p oi nts)
8
4
Se vere HI
Class C ( 1 0 t o 1 5 p oi nts)
4- 8 b
a.
A d diti o nal partici pa nts ma y be d ose d t o a ma xi m u m of 1 0 partici pa nts t o e ns ure mea n a ge ± 1 0 years a n d 
mea n b o d y wei g ht ± 1 5 k g of t his gr o u p is ali g ne d wit h t he p o ole d a vera ge assesse d w he n a p pr o xi matel y
≥7 5 % of partici pa nts are d ose d acr oss t he ot her 3 gr o u p s.
b.
T he t otal n u m ber of partici pa nts e nr olle d t hat are classifie d as ha vi n g se vere HI will be a mi ni m u m of 4 
t o a ma xi m u m of 8 de pe n di n g o n recr uit me nt rates.
Cate g orizati o n of partici pa nts i nt o Gr o u p s 2- 4 will be d o ne base d o n C hil d -P u g h sc ores 
deter mi ne d, as descri be d i n A p pe n di x 1 0 at t he scree ni n g visit.
St a ge d E nr oll me nt of St u d y Gr o u ps
Partici pa nts will be d ose d i n a sta ge d ma n ner as f oll o ws:

Partici pa nts wit h m o derate HI ( Gr o u p 3) a n d se vere HI ( Gr o u p 4) will be e nr olle d 
first.

Recr uit me nt of partici pa nts wit h mil d HI  ( Gr o u p 2) will i nitiate w he n 
a p pr o xi matel y 5 0 % of t he partici pa nts i n Gr o u p 3 ha ve bee n d ose d.

S p o ns or a p pr ov al is re q uire d bef ore pr ocee di n g wit h recr uit me nt of Gr o u p 2.

A n a vera ge val ue f or a ge a n d wei g ht f or t he 3 HI gr o u ps ( Gr o u ps 2 -4) will be 
deter mi ne d a n d partici pa nts wit h o ut HI  ( Gr o u p 1) will be recr uite d t o matc h t he 
a vera ge de m o gra p hics (at a mi ni m u m, a ge a n d wei g ht, a n d as m uc h as practicall y 
p ossi ble ge n der) acr oss t he p o ole d Gr o u ps 2- 4.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
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Page 28
!
Recruitment for healthy participants in Group 1 (without HI) may start when 
approximately 75% of total participants across Groups 2-4 (ie, approximately 15
to 18 participants) have been dosed.
!
Sponsor approval is required before proceeding with recruitment of Group 1.
Participants who prematurely discontinue before completing all assessments may be 
replaced, at the discretion of the investigator and sponsor study team.
The overall study design is presented as a schematic in Section 1.2 and below. For individual 
participants, the total duration of participation from the screening visit to the follow-up visit 
will range from approximately 5 weeks (minimum) to approximately 8 weeks (maximum).
The study consists of an initial screening period of up to 28 days (while allowing for the 
return and review of all results, including laboratory tests), a 6-day inpatient stay at the CRU 
which includes administration of a single oral dose of PF-07923568, and a follow-up contact 
that will occur 28-35 days after PF-07923568 administration.
4.2. Scientific Rationale for Study Design
The purpose of this study is to characterize the effect of varying degrees of HI on the PK, 
safety and tolerability of PF-07923568. A single dose of PF-07923568 is proposed, as single 
dose plasma PK of PF-07923568 is generally predictive of exposure upon repeated dosing.
Mean predicted accumulation index for a single dose of 175-350 mg comparable to the mean 
observed accumulation after multiple doses of 175-350 mg BID for 5 days.
There is uncertainty of the effect of HI on PF-07923568 PK. In vitro and in vivo studies 
indicate that PF-07923568 is predominantly eliminated through hepatic metabolism. 
CYP3A4 is the main CYP isoform that metabolizes PF-07923568 with minor contribution 
from CYPs 2C9 and 2D6. Based on review of the effect of hepatic impairment on human PK 
for compounds cleared in a similar manner to PF-07923568 (CYP3A-mediated metabolism), 
impaired hepatic function is generally associated with increased drug exposures in plasma 
(internal data and data cited in University of Washington Drug Interaction Database). 
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 9
H o we ver, t he ma g nit u de of t his i ncrease i n e x p os ure is varia ble bet wee n c o m p o u n ds wit h 
s o me bei n g o nly m o destl y i m pacte d, w hile ot hers e x hi bit i ncreases i n e x p os ure e ve n greater 
t ha n 2-f ol d w he n partici pa nts wit h se vere he patic i m pair me nt are c o nsi dere d. As s uc h, t his 
st u d y will e nr oll partici pa nts wit h var yi n g de grees of he patic i m pair me nt, a n d partici pa nts 
wit h o ut he patic i m pair me nt ( matc he d f or a ge as well as b o d y wei g ht a n d ge n der , as m uc h as 
practicall y p ossi ble) i n or der t o all o w a r o b ust assess me nt of P K acr oss t he e ntire s pectr u m of 
he patic f u ncti o n .
N o ncli nical st u dies i n dicate t hat t he cleara nce of sis u nat o vir f oll o wi n g oral a d mi nistrati o n t o 
rats is pre d o mi na ntl y he patic. A rat bile-d uct ca n n ulate d st u d y  s h o we d ne gligi ble re nal 
e xcreti o n ( St u d y P P N 7 0- 0 5 8. 0 4). F urt her m ore, a n A D M E (a bs or pti o n, distri b uti o n, 
meta b olis m, a n d e xcreti o n) st u d y i n male S pra g ue-Da wle y  rats t hat recei ve d a si n gle oral 
a d mi nistrati o n of [ 1 4C] -sis u nat o vir s h o we d t hat e xcreti o n was pre d o mi na ntl y via t he fecal 
r o ute a n d uri ne acc o u nte d f or < 4 % of t he d ose ( St u d y R V L/ 0 1). It is a ntici pate d t hat re nal 
e xcreti o n will be si milarl y l o w i n h u ma ns.
Gi ve n t he eli mi nati o n of sis u nat o vir via he patic e nz ymes wit h mi ni mal c o ntri b uti o n b y  re nal 
eli mi nati o n, it is e x pecte d t hat HI c o ul d ha ve a n effect o n t he cleara nce of sis u nat o vir.
F oll o wi n g a d mi nistrati o n of si n gle d oses of P F - 0 79 2 3 5 6 8, t he arit h metic mea n ter mi nal t ½ of 
P F - 0 79 2 3 5 6 8 ra n ge d fr o m 7 - 1 0 h o urs. E ve n wit h a p ossi ble m o dest i ncrease i n half -life, 
serial P K sa m ples will be c ollecte d o ver 1 2 0 h o urs p ost -d ose , w hic h is e x pecte d t o 
a de q uatel y c haracterize t he eli mi nati o n p hase of t he plas ma c o nce ntrati o n- ti me pr ofile i n t he 
c o h orts wit h var y i n g de grees of HI . T he pr otei n bi n di n g of P F - 0 7 9 2 3 5 6 8 i n h u ma ns is 3 3 %, 
res ulti n g i n a hi g h f u of 6 7 %.
A vaila ble P K data wit h P F - 0 7 9 2 3 5 6 8 a d mi nistere d u n der faste d or fe d c o n diti o ns i n dicate 
t hat P F-0 7 9 2 3 5 6 8 m a y  be a d mi nistere d wit h o ut re gar d t o f o o d. O verall, a d mi nstrati o n of 
P F -0 7 9 2 3 5 6 8 wit h f o o d res ults i n a sli g ht re d ucti o n i n o bser ve d varia bilit y a n d tre n de d 
t o war ds ha vi n g fe wer GI T E A Es . I n t his st u d y, a si n gle d ose of
m g P F -0 7 9 2 3 5 6 8 will be 
a d mi nistere d wit h a sta n dar d brea kfast t o reflect t he c o n diti o ns f or a ntici pate d use of 
P F -0 7 9 2 3 5 6 8 i n f ut ure trials.
I n ge neral, partici pa nts wit h n or mal he patic f u ncti o n ( Gr o u p 1) will a bstai n fr o m 
c o nc o mita nt treat me nts, e xce pt f or t he treat me nt of A Es . U se of selecte d li mite d prescri pti o n 
a n d n o n -prescri pti o n me dicati o ns ma y  be per mitte d (refer t o Secti o n 6. 9 f or details). 
Partici pa nts wit h i m paire d he patic f u ncti o n ( Gr o u ps 2- 4) are per mitte d t o be o n sta ble d oses 
of bac k gr o u n d me dicati o ns f or t he ma na ge me nt of t heir c o nc o mita nt me dical c o n diti o n(s) 
wit h s o me e xcl usi o ns ( see A p pe n di x 9 ). A cc or di n g t o t he D DI ris k assess me nt f or 
P F -0 7 9 2 3 5 6 8 as descri be d i n Secti o n 2. 2. 2 , sis u nat o vir is a m o derate i n hi bit or of C Y P 3 A 4 
a n d is pr ojecte d t o be a wea k i n hi bit or of C Y P 2 B 6. F or t his reas o n se nsiti ve a n d narr o w TI 
C Y P 3 A 4 s u bstrates a n d se nsiti ve narr o w TI C Y P 2 B 6 s u bs trates are pr o hi bite d i n t his st u d y. 
Si nce P F - 0 7 9 2 3 5 6 8 is a P-g p a n d C Y P 3 A 4 s u bstrate, str o n g a n d m o derate C Y P 3 A 4 
i n hi bit ors a n d str o n g P-g p i n hi bit ors are als o pr o hi bite d. L astl y, d ue t o ris k of M A T E 1 a n d 
O C T 1 i n hi biti o n, se nsiti ve s u bstrates of t hese tra ns p orters are pr o hi bite d.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 0
T o mi ni mize t he ris ks of C O VI D -1 9 relate d c o m plicati o ns t o partici pa nts a n d t he st u d y  site 
pers o n nel, assess me nt of ris k f or, s y m pt o ms of or testi n g f or C O VI D -1 9 ma y  be perf or me d at 
scree ni n g, a d missi o n t o t he C R U, a n d/ or at ot her ti mes d uri n g t he st u d y at i n vesti gat or 
discreti o n a n d acc or di n g t o l ocal site p olicies.
T he C hil d -P u g h Classificati o n (refer t o A p pe n di x 1 0 ) will be use d t o defi ne t he 3 gr o u ps of 
partici pa nts wit h var y i n g de grees of HI . T his st u d y will i ncl u de partici pa nts wit h mil d 
( C hil d- P u g h Class A, Gr o u p 2), m o derate ( C hil d -P u g h Class B, Gr o u p 3) , a n d se vere 
( C hil d-P u g h Class C, Gr o u p 4) HI as well as de m o gra p hic all y matc he d c o ntr ol partici pa nts 
wit h o ut HI ( Gr o u p 1). All partici pa nts will be re q uire d t o pr o vi de t heir o w n c o nse nt t o 
partici pate i n t his st u d y , he nce partici pa nts wit h cli nicall y acti ve Gra de 3 or Gra de 4 
e nce p hal o pat h y will be e xcl u de d. H o we ver, partici p a nts w h o ha ve a pre vi o us hist or y  of 
Gra de 3 or 4 e nce p hal o pat h y  b ut are c urre ntly recei vi n g a n i nter ve nti o n (e g , lact ul ose or 
lactit ol, al o ne or i n c o m bi nati o n wit h rifa xi mi n, a n d/ or ne o m yci n) t o ma na ge t heir 
e nce p hal o pat h y -relate d si g ns a n d sy m pt o ms are e li gi ble pr o vi de d t he o n-treat me nt 
e nce p hal o pat h y gra di n g at t he scree ni n g visit is Gra de 2 or l o wer, t here b y per mitti n g t he m t o 
pr o vi de t heir o w n i nf or me d c o nse nt. Ac k n o wle d gi n g t he me dical state of t he p o p ulati o n 
e nr olle d, certai n eli gi bilit y criteria f or partici pa nts wit h he patic i m pair me nt are disti nctl y  
differe nt, wit h n o s pecific e xcl usi o n of partici pa nts wit h He patitis B a n d He patitis C i n 
Gr o u ps 2- 4.
4. 2. 1. C h oice of C o ntr ace pti o n/ B arrier Re q uire me nts
H u ma n re pr o d ucti ve safet y  data are li mite d f or sis u nat o vir, b ut t here is n o s us pici o n of 
h u ma n terat o ge nicit y base d o n t he i nte n de d p har mac ol o g y of t he c o m p o u n d. T heref ore t he 
use of a hi g hl y effecti ve met h o d of c o ntrace pti o n is re q uire d f or all fertile partici pa nts (see
A p pe n di x 4 ).
4. 2. 2. C ollecti o n of Ret ai ne d Rese arc h S a m ples
Retai ne d Researc h Sa m ples will be c ollecte d a n d st ore d f or f urt her a nal ys es w hic h ma y, f or 
e xa m ple, pr o vi de greater u n dersta n di n g of t he st u d y  i nter ve nti o n.
4. 3. J ustific ati o n f or D ose
W hile t here is u ncertai nt y  of t he effects of HI o n t he e x p os ure of P F-0 7 9 2 3 5 6 8 a n d t he 
meta b olis m b y  C Y P 3 A 4, t he pr o p ose d d ose of 
m g is e x pecte d t o be safe a n d 
well -t olerate d i n partici pa nts wit h HI.
T his d ose has bee n selecte d base d o n pri or e x perie nce i n cli nical st u dies wit h P F- 0 7 9 2 3 5 6 8 
(Secti o n 2. 2. 4 ) de m o nstrati n g t hat it is safe a n d well t olerate d.
T he cli nical pr o gra m f or 
P F -0 7 9 2 3 5 6 8 has e val uate d d oses u p t o 3 5 0 m g t wice dail y ( BI D) f or 5 da ys t o date
T he cli nical pr o gra m f o r P F- 0 7 9 2 3 5 6 8 has e val uate d d oses u p t o 3 5 0 m g t wice daily ( BI D )
f or 5 d a y s t o date. P F -0 7 9 2 3 5 6 8 was ge nerall y well t olerate d i n t he viral c halle n ge st u d y 
( C 5 2 4 1 0 0 2) as well as ot her P hase 1 st u dies c o n d ucte d t o date. H o we ver, u n der fasti n g 
c o n diti o ns a n increase d i nci de nce of GI A Es , pri maril y mil d a n d m o derate HI, were o bser ve d 
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 1
at t he 3 5 0 m g d ose relati ve t o t he 2 0 0 m g d ose. Hi g her rates of GI A Es were als o o bser ve d at
hi g her d oses wit hi n t he P hase 1 pr o gra m. I n t hese st u dies, sis u nat o vir was d ose d i n a f aste d
state. Alt h o u g h i m pr o ve d GI t olera bilit y has bee n o bser ve d f or s o me a nti-i nfecti ve a ge nts
w he n d ose d wit h f o o d, it is n ot clear if GI  t olera bilit y of sis u nat o vir will i m pr o ve wit h f o o d.
T he effect of f o o d o n t he P K of sis u nat o vir has bee n varia ble i n P hase 1 st u dies. H o we ver, 
t he effect of f o o d o n t he P K of sis u nat o vir usi n g t he f or m ulati o n t o be use d i n t his st u d y  
(D P B i n ca ps ules) s h o we d mi ni mal f o o d effect acc o m pa nie d b y a decrease i n o bser ve d 
varia bilit y . Gi ve n t he a b o ve, it is a ntici pate d t hat wi t h a si ngl e 
m g d ose p ote ntial 
i ncreases i n plas ma e x p os ure i n partici pa nts wit h var yi n g de grees of he patic i m pair me nt i n 
t he c urre nt st u d y, if e nc o u ntere d, are n ot a ntici pate d t o p ose a n u n d ue safet y ris k. 
4. 4. E n d of St u d y Defi niti o n
T he e n d of t he st u d y is defi ne d as t he date of t he f oll o w- u p as s h o w n i n t he S o A f or t he last 
partici pa nt i n t he trial gl o ball y .
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y  if t he y ha ve c o m plete d all p hases of 
t he st u d y, i ncl u di n g t he f oll o w-u p visit ( tele p h o ne c o ntact or o n site visit per in vesti gat or 
discreti o n ) as s h o w n i n t he S o A .
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nt s are e nr olle d, i ncl u di n g 
par tici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. Use of a 
prescree n i n g t o ol is utilize d f or st u dy recr uit me nt p ur p oses , it will i ncl u de c ollecti o n of 
i nf or mati o n t hat reflects t he e nr oll me nt of a di verse partici pa nt p o p ulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, a n d race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y 
criteria are desi g ne d t o select partic i pa nts f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria , als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
5. 1. 1. P artici p a nts i n All Gr o u p s
A ge a n d Se x :
1.
Male or fe male bet wee n t he a ges of 1 8 ( or t he mi ni m u m c o u ntr y-s pecific a ge of 
c o nse nt if > 1 8) a n d 7 5 ye ars, i ncl usi ve, at t he scree ni n g visit .
W O C B P, h o we ver, ca n n ot be pre g na nt, breastfee di n g, or pla n ni n g t o bec o me 
pre g na nt w hile partici pati n g i n t he st u d y . Refer t o A p pe n di x 4 f or re pr o d ucti ve 
criteria f or male ( Secti o n 1 0. 4. 1 ) a n d fe male (Secti o n 1 0. 4. 2 ) partici pa nts.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
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Other Inclusion Criteria:
2. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, 
lifestyle considerations (as described in Section 5.3), and other study procedures.
3. BMI of 17.5 to 38.0 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the 
screening visit; with a single repeat assessment of total body weight (and hence BMI), 
on a separate day before Day -1 permitted to assess eligibility, if needed.
4. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
5.1.2. Additional Inclusion Criteria for Group 1 Only (without HI)
1. At screening, no clinically relevant abnormalities identified by a detailed medical 
history, complete PE, including BP and pulse rate measurement, 12-lead ECG and 
clinical laboratory tests, as assessed by the sponsor approved laboratory.
2. At screening, participants must meet the demographic-matching criteria, including:
!
A body weight that is within ±15 kg of the average of the pooled hepatic 
impairment groups (Groups 2-4), as provided by the sponsor;
!
An age that is within ±10 years of the average of the pooled hepatic impairment 
groups (Groups 2-4), as provided by the sponsor;
!
Attempts will be made to ensure that the male-to-female distribution in Group 1 is 
comparable to that in the pooled hepatic impairment groups (Groups 2-4).
3. No known or suspected hepatic impairment, and meet all the following criteria at 
screening, as assessed by the sponsor approved laboratory, with a single repeat 
permitted to assess eligibility, if needed:
!
ALT ≤ ULN;
!
AST ≤ ULN;
!
T bili ≤ ULN.
NOTE: Participants with a history of Gilbert syndrome (and hence elevated T bili) 
are eligible provided direct bilirubin level is ≤ULN plus ALT and AST are ≤ULN 
plus alkaline phosphatase, hemoglobin, and reticulocyte count are all ≤ULN.
!
Albumin ≤ ULN;
!
PT ≤ ULN.
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5.1.3. Additional Inclusion Criteria for Groups 2-4 Only (Mild, Moderate, and Severe
HI)
1. Stable hepatic impairment that meets the criteria for Class A, B, or C of the
Child-Pugh classification (refer to Appendix 10) with no clinically significant change 
in disease status within the 28 days prior to the screening visit, as documented by the 
participant’s recent medical history (eg, no worsening clinical signs of hepatic 
impairment, no worsening of T bili or PT by more than 50%).
2. Stable concomitant medications for the management of individual participant’s 
medical history; on a case-by-case basis, with approval from the sponsor, participants 
receiving fluctuating concomitant medication/treatment may be considered if the 
underlying disease is under control.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
5.2.1. Participants in All Groups
Medical Conditions:
1. Any condition possibly affecting drug absorption (eg, prior bariatric surgery, 
gastrectomy, ileal resection).
NOTE: Participants who have undergone cholecystectomy and/or appendectomy are 
eligible for this study as long as the surgery occurred more than 6 months prior to 
screening.
2. At screening, a positive result for HIV antibodies, as assessed by sponsor approved 
laboratory, with a single repeat permitted to assess eligibility, if needed.
3. History of surgery that would be expected to alter absorption, distribution, 
metabolism, or excretion properties of PF-07923568 (eg, status post portacaval shunt 
surgery).
NOTE: Participants with a trans-jugular intrahepatic portosystemic shunt are 
permitted provided that they meet the Child-Pugh criteria.
4. Other medical or psychiatric condition including recent (within the past year) or 
active suicidal ideation/behavior or laboratory abnormality or other conditions or 
situations related to COVID-19 pandemic (eg, contact with positive case) that may 
increase the risk of study participation or, in the investigator’s judgment, make the 
participant inappropriate for the study.
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Prior/Concomitant Therapy
5. Use of specific prohibited prior/concomitant therapies as outlined in Section 6.9, 
Appendix 9.  Previous administration with an investigational product (drug or 
vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives 
preceding the first dose of study intervention used in this study (whichever is longer). 
Investigational products which are strong CYP3A inducers or time-dependent 
inhibitors are prohibited within 14 days plus 5 half-lives prior to the dose of study 
intervention.
Prior/Concurrent Clinical Study Experience:
6. Known prior participation (ie, received at least 1 dose of study intervention) in a 
study involving PF-07923568.
Diagnostic Assessments:
7. eGFR <60 mL/min/1.73m2 (calculated with the 2021 CKD-EPI Scr-Scys combined 
equation, see Appendix 7), at the screening visit, as assessed by the sponsor approved 
laboratory, and confirmed by a single repeat test, if deemed necessary.
8. A positive urine drug test at screening or Day -1. However, participants in 
Groups 2-4, only, who have been medically prescribed medications, 
eg, opiates/opioids, cannabinoids, benzodiazepines, methylphenidate (or similar), and 
report the use of these drugs to the investigator at the screening visit may be allowed 
to participate, after approval from the sponsor, and if in line with protocol 
specifications regarding prohibited medications (see Section 6.9, Appendix 9).
NOTE: Repeat urine drug testing to assess study eligibility at screening or Day -1 is 
not permitted in this study.
9. At screening or Day -1, a positive breath alcohol test, as assessed using kits approved 
by sponsor; for the screening test, a single repeat (which may be on a separate day)
before Day -1 is permitted to assess eligibility, if needed.
10. For females, pregnancy, as indicated by a positive serum pregnancy test at screening 
and/or positive urine pregnancy test in WOCBP at Day -1.
11. If performed at investigator discretion, safety related laboratory tests collected on 
Day -1, upon review prior to dosing reflect the participant not to be in stable medical 
condition.
Other Exclusion Criteria:
12. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or 
more within 60 days prior to dosing and until the follow-up contact.
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13. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin 
is used to flush IV catheters used during serial blood collections.
14. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
5.2.2. Additional Exclusion Criteria for Group 1 Only (without HI)
1. Evidence of chronic liver disease including history of hepatitis, hepatitis B, or 
hepatitis C or evidence of any of the following, as assessed by sponsor approved 
laboratory, with a single repeat, permitted to assess eligibility, if needed:
!
Hepatitis B virus, defined by presence of hepatitis B surface antigen (HBsAg);
NOTE: while not part of the tests assessed in this study, a previously positive 
hepatitis B surface antibody result due to vaccination is permissible.
!
Hepatitis C infection, defined by presence of HCVAb and HCV RNA.
2. History of alcohol abuse or binge drinking and/or any other illicit drug use or 
dependence within 6 months of screening. Binge drinking is defined as a pattern of 
5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, 
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 
1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine.
3. Screening supine standard 12-lead ECG demonstrating QTcF interval >450 ms or a 
QRS interval >120 ms. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG 
should be repeated 2 more times and the average of the 3 QTcF or QRS values should 
be used to determine the participant’s eligibility.
4. Screening seated SBP ≥140 mmHg or DBP ≥90 mmHg, following ≥5 minutes of 
seated rest. If SBP is ≥140 mmHg or DBP ≥90 mmHg, the BP assessment should be 
repeated 2 more times and the average of the 3 BP values should be used to determine 
eligibility.
5. Use of chronic prescription medications within 7 days or 5 half-lives (whichever is 
longer) prior to Day 1, or for prohibited medications, use within the required 
washout/restriction period provided in Appendix 9.
NOTE: Use of selected, limited prescription and non-prescription medications may 
be permitted on a case-by-case basis after approval from the sponsor (refer to 
Section 6.9 for details).
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5.2.3. Additional Exclusion Criteria for Groups 2-4 Only (Mild, Moderate, and Severe
HI)
1. Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy 
(defined as <1 year).
2. A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular 
process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, 
CT scan, or MRI.
3. History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less 
than 4 weeks prior to the screening visit.
4. Signs of clinically active Grade 3 or 4 hepatic encephalopathy (ie, >Grade 2 Portal 
Systemic Encephalopathy score; refer to Appendix 10).
5. Severe ascites and/or pleural effusion, except for those categorized in Group 4 who 
may be enrolled provided participant is medically stable, per the investigators’ 
medical judgment.
6. Previously received a kidney, liver, or heart transplant.
7. Screening supine 12-lead ECG demonstrating a QTcF interval >470 ms or a QRS 
interval >120 ms. If QTcF exceeds 470 ms, or QRS exceeds 120 ms, the ECG should 
be repeated 2 more times and the average of the 3 QTcF or QRS values should be 
used to determine eligibility.
8. At screening, Day -1 or pre-dose on Day 1, persistent severe, uncontrolled 
hypertension as outlined below:
!
Seated SBP ≥180 mmHg or DBP ≥105 mmHg after ≥5 minutes of seated rest, 
with a single repeat permitted to assess eligibility, if needed, at each of these 2 
visits; if done, the repeat assessment overrides initial results.
NOTE: For participants with SBP ≥160 and ≤179 mmHg or DBP ≥100 and 
≤104 mmHg at screening, the period between screening and Day 1 may be used to 
refine the doses of the agents used for management of BP with the aim of having
stable BP by Day -1.
!
Day 1: seated SBP ≥160 mmHg or DBP ≥100 mmHg after ≥5 minutes of seated 
rest, with a single repeat permitted to assess eligibility, if needed; if done, the 
repeat assessment overrides initial results.
9. ALT or AST >5x ULN on clinical laboratory tests at screening, as assessed by the 
sponsor approved laboratory, with a single repeat permitted to assess eligibility, if 
needed.
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5.3. Lifestyle Considerations
After confirmation of eligibility, participants will be instructed to maintain the guidelines 
described below for the duration of participation in the study.
5.3.1. Contraception
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is utilizing an appropriate method of contraception for the individual participant 
from the permitted list of contraception methods (see Appendix 4, Section 10.4.4) and will 
confirm that the participant has been instructed in its consistent and correct use. At time 
points indicated in SoA, the investigator or designee will inform the participant of the need to 
use highly effective contraception consistently and correctly and document the conversation 
and the participant’s affirmation in the participant’s chart. Participants need to affirm their 
consistent and correct use of at least 1 of the selected methods of contraception, considering 
that their risk for pregnancy may have changed since the last visit.
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
5.3.2. Meals and Dietary Restrictions
!
Participants must abstain from all food and drink (except water) at least 4 hours prior 
to all fasting clinical laboratory evaluations and pre-dose PK sample (0.5 hrs prior to 
dosing) on Day 1.
!
Water may be consumed as desired (ad libitum).
!
While inpatient, all meals will be standardized as follows:
! On Day 1, following a fast of at least 4 hours, participants should begin breakfast 
approximately 30 minutes prior to PF-07923568 administration. The breakfast 
will be consumed over approximately a 20-minute period with PF-07923568
administered within approximately 10 minutes after completion of the meal. 
Participants will be encouraged to complete the entire breakfast. There will be no 
water restrictions prior to dosing.
!
Standard morning meal, lunch, an optional afternoon snack, an evening meal, and 
an optional evening snack will be provided at a similar clock time to the clock 
time when these meals are provided relative to dosing on Day 1 while inpatient 
ie, approximately 0, 4, 6 (optional snack), 10, and 14 hrs (optional snack).
!
The total daily nutritional composition should be approximately 
55% carbohydrate, 30% fat and 15% protein. The nutritional macronutrient 
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composition consumed by each participant should be maintained, as much as 
practically possible.
!
The daily caloric intake per participant should not exceed approximately 
3200 kcal.
!
Participants will refrain from consuming red wine, grapefruit, or grapefruit-
related citrus fruits (eg, Seville oranges, pomelos, fruit juices) from 7 days prior to 
Day 1 and until collection of the final PK blood sample.
!
When a meal or snack is scheduled at the same time as an ECG and/or VS
assessments, the meal will be provided after the ECG and/or VS assessments are
completed.
5.3.3. Caffeine, Alcohol, and Tobacco
!
Participants will abstain from alcohol for ≥24 hrs prior to admission for inpatient stay 
(and for red wine abstain for at least 7 days prior to Day 1), plus have a negative 
breath alcohol test on Day 1 and continue abstaining from alcohol until collection of 
the final PK blood sample.
!
Participants will undergo breath alcohol tests at timepoints indicated in the SoA, 
additional tests may be conducted at investigator discretion
!
Consumption of caffeinated drinks and tobacco (or nicotine containing products) is 
permitted during participation in the study; however, there may be a need for brief 
interruption while at the site, depending on local site policy.
In addition:
!
Participants must abstain from caffeine-containing products for a minimum of 2 hrs 
prior to all vital signs and ECG measurements conducted throughout study 
participation (from screening to the final follow-up).
!
Smoking may not be permitted when it would interfere with the timing of scheduled 
study procedures. In addition, participants must abstain from use of tobacco- or 
nicotine-containing products: for a minimum of 2 hrs prior to all vital signs and ECG 
measurements, for a minimum of 2 hrs prior to and following administration of study 
intervention.
5.3.4. Activity
!
Participants will not be permitted to engage in physically strenuous exercise 
(eg, heavy lifting, weight training, calisthenics, and aerobics) within 48 hrs before 
each blood sample collection for clinical laboratory tests while participating in the 
study; physical activity at an individual participant’s normal pace is permitted.
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 9

I n or der t o sta n dar dize t he c o n diti o ns o n P K sa m pli n g da ys, all partici pa nts will be 
re q uire d t o refrai n fr o m l yi n g d o w n (e xce pt if re q uire d f or st u d y pr oce d ures, 
e g, E C G), eati n g, a n d dri n ki n g be vera ges ot her t ha n water d uri n g t he first 4 h o urs 
after d osi n g.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o pa rtici pate i n t he cli nical st u d y b ut 
are n ot s u bse q ue ntl y e nr olle d i n t he st u d y. Scree n fail ure data are c ollecte d a n d re mai n as 
s o urce a n d are n ot re p orte d o n t he C R F .
I n t his st u dy, partici pa nts ma y be rescree ne d o nl y after c o ntact wit h a sp o ns or Cli nical
re prese ntati ve. T his m a y  be per mitte d w he n, f or e xa m ple d ue t o l o gistical c o nstrai nts or 
a d mi nistrati ve reas o ns , t he ma xi m u m peri o d bet wee n scree ni n g visit a n d Da y 1, of 2 8 d a ys,
is e xcee de d. I n a d diti o n, f or partici pa nts i n Gr o u p s 2- 4 o nly , rescree ni n g ma y be a p pr o priate 
f oll o wi n g mil d i nterc urre nt ill ness after t he c o n diti o n has res ol ve d. Ot her wise, in di vi d uals 
w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y  (scree n fail ure) ma y n ot be 
rescree ne d.
I n cases w here rescree ni n g is per mitte d , all scree ni n g pr oce d ures m ust be re peate d a n d t he 
partici pa nt assi g ne d a ne w 8- di git S SI D n u m ber. Partici pa nts m ust be dee me d t o meet all t he 
eli gi bilit y criteria u n der t he ne w 8 di git S SID bef ore pr o gressi n g t o Da y 1. Rec o nse nt is 
re q uire d.
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal pr o d ucts, me dical de vices, a n d ot her 
i nter ve nti o ns (e g, s ur gical a n d be ha vi oral) i nte n de d t o be a d mi nistere d t o t he st u d y 
partici pa nts d uri n g t he st u d y  c o n duct.
F or t he p ur p oses of t his pr ot oc ol, st u d y i nter ve nti o n refers t o P F - 0 7 9 2 3 5 6 8.
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F - 0 79 2 3 5 6 8
Ar m N a me
( gr o u p of p artici p a nts recei vi n g a 
s pecific tre atme nt or n o tre at me nt)
Gr o u p 1, Gr o u p 2, Gr o u p 3 , Gr o u p 4
T y pe
Dr u g
D ose F or m ul ati o n
Ca ps ule
U nit D ose Stre n gt h(s)
m g
D os a ge Le vel(s)
m g , si n gle d ose
R o ute of A d mi nistr ati o n
Oral
Use
E x peri me ntal
I M P or NI M P/ A x M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y t he s p o ns or . Refer t o t he I M P.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 0
St u d y I nter ve nti o n(s)
P ac k a gi n g a n d L a beli n g
St u d y i nter ve nti o n will be pr o vi de d as o pe n -la bel s u p pl y i n b ul k b ottles
al o n g wit h i n di vi d ual d ose c o ntai ners, as necessar y, f or u nit d osi n g.
C urre nt/ F or mer N a me(s) or Ali as(es)
P F -0 7 9 2 3 5 6 8
Sis u nat o vir
R V 5 2 1
A r m  Title
Gr o u p 1
Gr o u p 2
Gr o u p 3
Gr o u p 4
A r m  T y pe
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal
A r m  
Descri pti o n
Partici pa nts 
wit h o ut HI will 
recei ve a si n gle 
m g d ose of 
P F -0 7 9 2 3 5 6 8, 
a d mi nistere d orall y 
as 4 P F -0 7 0 8 1 5 3 2 
m g ca ps ules
Partici pa nts wit h 
mil d HI will recei ve 
a si n gle 
m g d ose 
of P F -0 7 9 2 3 5 6 8, 
a d mi nistere d orall y 
as 4 P F -0 7 0 8 1 5 3 2 
m g ca p s ules
Partici pa nts wit h 
m o derate HI will 
recei ve a si n gle 
m g d ose of 
P F -0 7 9 2 3 5 6 8, 
a d mi nistere d orall y 
as 4 P F -0 7 0 8 1 5 3 2 
m g ca ps ules
Partici pa nts wit h 
se vere HI will 
recei ve a si n gle 
m g d ose of 
P F -0 7 9 2 3 5 6 8, 
a d mi nistere d orall y 
as 4 P F -0 7 0 8 1 5 3 2 
m g ca ps ules
Ass oci ate d 
I nter ve nti o n 
L a bels
P F -0 7 9 2 3 5 6 8
P F -0 7 9 2 3 5 6 8
P F -0 7 9 2 3 5 6 8
P F -0 7 9 2 3 5 6 8
P F - 0 79 2 3 5 6 8 will be s u p plie d b y  Pfizer as
m g  ca ps ules i n o pe n -la bel b ul k b ottles al o n g 
wit h i n di vi d ual d osi n g c o ntai ners, as necessar y , f or u nit d osi n g. F or t he
m g d ose 
a d mi nistere d i n t his st u d y, partici pa nts will ta ke 4 P F - 0 7 9 2 3 5 6 8
m g ca ps ules , orall y , wit h 
t he m or ni n g meal as descri b e d i n Secti o n 5. 3. 2 .
6. 1. 1. A d mi nistr ati o n
F oll o wi n g a n o ver ni g ht fast of at least 8 hrs, partici pa nts will recei ve brea kfast as o utli ne d i n 
Secti o n 5. 3. 2 ( Meals a n d Dietar y Restricti o ns). T he partici pa nts will t he n recei ve st u d y 
i nter ve nti o n at a p pr o xi matel y 0 8: 0 0 hrs ( pl us or mi n us 2 hrs) o n Da y 1. I n vesti gat or site 
pers o n nel will a d mi nister st u d y i nter ve nti o n wit h a m bie nt te m perat ure water t o a t otal 
v ol u me of a p pr o xi m ately 1 2 0 m L . Partici pa nts ma y recei ve a d diti o nal a m bie nt te m perat ure 
water u p t o 1 2 0 m L, if nee de d. Partici pa nts will s wall o w t he st u d y i nter ve nti o n w h ole a n d 
will n ot ma ni p ula te or c he w t he st u d y i nter ve nti o n pri or t o s wall o wi n g.
6. 2. Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y
1.
T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns 
(e g, te m perat ure) ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns
recei ve d a n d a ny discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y  
i nter ve nti o n.
2.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y  s u p pl y, pre pare, a n d/or a d mi nister st u d y  i nter ve nti o n.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 41
3. All study interventions must be stored in a secure, environmentally controlled, and 
monitored (manual or automated recording) area in accordance with the labeled 
storage conditions with access limited to the investigator and authorized site staff. At 
a minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request. Data for non-working days must 
indicate the minimum and maximum temperatures since previously documented upon 
return to business.
4. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with actions taken. The site should actively 
pursue options for returning the study intervention to the labeled storage conditions, 
as soon as possible. Once an excursion is identified, the study intervention must be 
quarantined and not used until Pfizer provides permission to use the study 
intervention. Specific details regarding the excursion definition and information to
report for each excursion will be provided to the site in the IPM.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, 
reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records), such as the IPAL or sponsor-approved equivalent. All study 
interventions will be accounted for using a study intervention accountability 
form/record.
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IPM. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with 
applicable environmental regulations, institutional policy, and any special instructions 
provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IPM.
6.2.1. Preparation and Dispensing
Within this protocol, preparation refers to the investigator site activities performed to make 
the study intervention ready for administration or dispensing to the participant by qualified 
staff. Dispensing is defined as the provision of study intervention, concomitant treatments, 
and accompanying information by qualified staff member(s) to a healthcare provider, 
participant, in accordance with this protocol. Local health authority regulations or 
investigator site guidelines may use alternative terms for these activities.
090177e19cb785b2\Approved\Approved On: 24-Feb-2023 02:23 (GMT)


P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 2
Ca ps ules will be pre pare d at t he C R U i n t he i n di vi d ual d osi n g c o ntai ners b y  2 o perat ors, 1 of 
w h o m is a n a p pr o priatel y q ualifie d a n d e x perie nce d me m ber of t he st u d y staff (e g, p h ys icia n, 
n urse, p h ys icia n’s assista nt, n urse practiti o ner, p har mac y assista nt/tec h nicia n, or p har macist). 
T he ca ps ules will be pr o vi de d i n u nit d ose c o ntai ners a n d la bele d i n acc or da nce wit h Pfizer 
re g ulati o ns a n d t he cli nical site’s la beli n g re q uire me nts.
6. 3. Assi g n me nt t o St u d y I n terve nti o n
T his is a n o pe n -la bel st u d y i n w hic h eac h partici pa nt d ose d will recei ve a si n gle 
m g  d ose 
of P F - 0 7 9 2 3 5 6 8. F oll o wi n g c o m pleti o n of i nf or me d c o nse nt at t he scree ni n g visit, eac h 
partici pa nt will be assi g ne d a si n gle 8 -di git S SI D n u m ber b y  t he site staff. T he first 4 di gits 
of t he S SI D will reflect t he s p o ns or -assi g ne d site n u m ber a n d t he re mai ni n g 4 di gits will 
reflect eac h partici pa nt’s u ni q ue n u m ber assi g ne d i n c hr o n ol o gical or der of w he n i nf or me d 
c o nse nt is o btai ne d. Eac h partici pa nt w h o is d ose d wit h st u d y  i nter ve nti o n will als o be 
assi g ne d a se parate, disti nct n u m ber (as pr o vi de d t o t he site b y  t he sp o ns or), t o e na ble 
e xec uti o n of t he sp o ns or’s sta n dar d pr ocesses f or a nal y sis of P K sa m ples.
6. 4. Bli n di n g
T his is a n o pe n -la bel st u d y.
6. 4. 1. Bli n di n g of P a rtici p a nts
Partici pa nts will be u n bli n de d t o t heir assi g ne d st u d y i nter ve nti o n.
6. 4. 2. Bli n di n g of Site Pers o n nel
I nvesti gat ors a n d ot her site staff will be u n bli n de d t o partici pa nts’ assi g ne d st u d y 
i nter ve nti o n.
6. 4. 3. Bli n di n g of t he S p o ns or
S p o ns or staff will be u n bli n de d t o partici pa nts’ assi g ne d st u dy i nter ve nti o n.
6. 5. St u d y I nter ve nti o n C o m pli a nce
W he n t he i n di vi d ual d ose f or a partici pa nt is pre pare d fr o m a b ul k s u p pl y, t he pre parati o n of 
t he d ose will be c o nfir me d b y a sec o n d q ualifie d me m ber of t he st u d y site staff.
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he date a n d ti me of eac h d ose 
a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce d oc u me nts a n d rec or de d i n t he C R F. 
T he d ose of st u d y i nter ve nti o n a n d st u d y partici pa nt i de ntificat i o n will be c o nfir me d at t he 
ti me of d osi n g by a me m ber of t he st u d y site staff ot her t ha n t he pers o n a d mi nisteri n g t he 
st u d y i nter ve nti o n. St u d y site pers o n nel will e xa mi ne eac h partici pa nt’s m o ut h t o e ns ure t hat 
t he st u d y i nter ve nti o n was i n geste d.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
C CI


PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 43
A record of the number of study intervention capsules dispensed to and taken by each 
participant must be maintained and reconciled with study intervention and compliance 
records.
6.6. Dose Modification
Dose modification of PF-07923568 is not allowed.
6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants at the end of their study participation.
6.8. Treatment of Overdose
For this study, any dose of PF-07923568 greater than 1200 mg within a 24-hour time period
will be considered an overdose.
There is no specific treatment for an overdose.
In the event of an overdose, the investigator/treating physician should:
1. Contact the study medical monitor within 24 hrs.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities as 
medically appropriate and at least until the next scheduled follow-up.
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
5. Obtain a blood sample for PK analysis within 3 days from the date of the last dose of 
study intervention if requested by the study medical monitor (determined on a 
case-by-case basis).
6.9. Prior and Concomitant Therapy
All concomitant treatments taken during the study must be recorded with indication, daily 
dose, and start and stop dates of administration. All participants will be questioned about 
concomitant treatment at each clinic visit.
Treatments taken within 28 days before study intervention dosing on Day 1 will be 
documented as a prior treatment. Treatments taken after the first dose of study intervention
will be documented as concomitant treatments.
Females using hormonal contraceptives or taking hormone replacement therapy are eligible 
to participate in this study. See Appendix 4 for hormonal contraceptives that are permitted in 
this study.
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 44
Participants on certain medications are excluded from the study (see Appendix 9 for list of 
prohibited medications due to potential drug-drug interaction ).
Sites are encouraged to contact the sponsor should there be questions as to whether a 
medication is permitted or prohibited.
6.9.1. Participants in Group 1 Only (without Hepatic impairment)
In general, participants in Group 1 (without HI) will abstain from all concomitant treatments, 
except for the treatment of AEs. Of note, are the following restrictions:
!
Acetaminophen/paracetamol may be used at doses of ≤1 g/day;
!
Herbal supplements must be discontinued at least 28 days prior to Day 1 and until the 
follow-up;
!
Limited use of prescription and nonprescription medications that are not believed to 
affect the overall results of the study may be permitted on a case-by-case basis after 
approval from the sponsor study team.
6.9.2. Participants in Groups 2-4 Only (Hepatic Impairment)
Participants in Groups 2-4 (with HI) are permitted to be on stable doses of background 
medications for the management of their concomitant medical condition(s), as long as this is 
in line with protocol specifications regarding prohibited medications as described above in 
Section 6.9 and in Appendix 9. On a case-by-case basis, with approval from the sponsor, 
participants receiving fluctuating concomitant medication/treatment may be considered if the 
underlying disease is under control. Whenever possible, attempts must be made to not add 
new medications or alter the doses and regimens of the concomitant medications after 
enrollment and for the duration of participation in this study, except in circumstances where a 
change is deemed medically necessary. Any changes must be captured in the CRF.
Participants may receive any permitted background medications according to their stable 
medication routine at their usual dosing times. This is with the exception of phosphate 
binders, antacids, and bile acid binding resins (eg, cholestyramine, colestipol), which must 
not be administered within the 8 hrs before study intervention dosing or within the 4 hrs after 
study intervention dosing on Day 1. On Day 1, the investigator will determine the 
appropriate time to administer medications that are to be taken on an empty stomach. 
Otherwise, permitted concomitant medications that may be administered under fed 
conditions can be taken with breakfast on the morning of Day 1. On all other study days, 
participants are to receive their background medications at their usual times.
6.9.3. Rescue Medicine
There is no rescue therapy to reverse AEs observed with PF-07923568; standard medical 
supportive care must be provided to manage any AEs.
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
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Page 45
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is NA.
7.2. Participant Discontinuation/Withdrawal from the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following: safety, behavioral, compliance or 
administrative reasons, or if the study is terminated by sponsor.
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted. See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed.
The early discontinuation visit applies only to participants who are enrolled and then are 
prematurely withdrawn from the study. Participants should be questioned regarding their 
reason for withdrawal. The participant will be permanently discontinued from the study 
intervention and the study at that time.
If a participant withdraws from the study, they may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations will be performed and no 
additional data will be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
7.2.1. Withdrawal of Consent
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with them or persons previously authorized by the participant to provide this information. 
Participants should notify the investigator in writing of the decision to withdraw consent 
from future follow-up, whenever possible. The withdrawal of consent should be explained in 
detail in the medical records by the investigator, as to whether the withdrawal is only from 
further receipt of study intervention or also from study procedures and/or post-treatment 
study follow-up, and entered on the appropriate CRF page. In the event that vital status 
(whether the participant is alive or dead) is being measured, publicly available information 
should be used to determine vital status only as appropriately directed in accordance with 
local law.
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
Page 46
7.3. Lost to Follow-up
A participant will be considered lost to follow-up if the participant repeatedly fails to return 
for scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to attend a required study visit:
!
The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible. Counsel the participant on the importance of maintaining the
assigned visit schedule and ascertain whether the participant wishes to and/or should 
continue in the study;
!
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record;
!
Should the participant continue to be unreachable, the participant will be considered 
to have withdrawn from the study.
8. STUDY ASSESSMENTS AND PROCEDURES
8.1. Administrative Procedures
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Participants will be screened within 28 days prior to administration of the study intervention 
to confirm that they meet the study population criteria for the study. If the time between 
screening and dosing exceeds 28 days as a result of unexpected delays (eg, delayed drug 
shipment), then participants may be rescreened after contact with a sponsor Clinical 
representative as described in Section 5.4.
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PF-07923568
Protocol C5241012
Final Protocol, 23 February 2023
PFIZER CONFIDENTIAL
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Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that make it unfeasible to perform the 
test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that they have taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
If done around the time of a blood draw, ECGs and vital sign assessments (BP and pulse rate)
should be collected before the blood draw. If an IV catheter is utilized for blood sample 
collections, ECGs and vital sign assessments (BP and pulse rate) should be collected before
insertion of the catheter.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants in this study is approximately 
95 m. The actual collection times of blood sampling may change. Additional blood samples 
may be taken for safety assessments at times specified by Pfizer, provided the total volume 
taken during the study does not exceed 550 mL during any period of 56 consecutive days.
To prepare for study participation, participants will be instructed on the information in the 
Lifestyle Considerations and Concomitant Therapy sections of the protocol.
8.2. Efficacy Assessments
NA.
8.3. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. Unscheduled safety
measurements may be obtained at any time during the study to assess any perceived safety 
issues.
8.3.1. Physical Examinations
A complete PE will include, at a minimum, head, ears, eyes, nose, mouth, neck, skin, heart 
and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological 
systems.
A limited PE will include, at a minimum, assessments of general appearance, the respiratory 
and cardiovascular systems, and participant-reported symptoms.
PEs may be conducted by a physician, trained physician’s assistant, or nurse practitioner as 
acceptable according to local regulation.
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Height and weight will also be measured per the SoA and recorded in the CRF. For 
measuring weight, a scale with appropriate range and resolution is used and must be placed 
on a stable, flat surface. Participants must remove shoes, bulky layers of clothing, and jackets 
so that only light clothing remains. They must also remove the contents of their pockets and 
remain still during measurement of weight.
PE findings collected during the study will be considered source data and will not be required 
to be reported, unless otherwise noted. Any untoward PE findings that are identified during 
the active collection period and meet the definition of an AE or SAE (Appendix 3) must be 
reported according to the processes in Section 8.4.1 to 8.4.3.
8.3.2. Vital Signs
8.3.2.1. Blood Pressure and Pulse Rate
BP and pulse rate will be measured as defined in the SoA.
!
Single, seated BP and pulse rate will be measured with the participant’s arm 
supported at the level of the heart, and recorded to the nearest mmHg, following a rest 
of ≥5 minutes;
!
Same arm (preferably the dominant arm) will be used for BP/pulse rate assessment 
throughout the study;
!
BP/pulse rate assessment should not be taken from the arm with an IV catheter, if 
placed;
!
Participants should be instructed not to speak during BP/pulse rate measurements.
The same properly sized and calibrated BP cuff will be used to measure BP each time. The 
use of an automated device for measuring BP and pulse rate is acceptable; however, when 
done manually, pulse rate will be measured in the brachial/radial artery for at least
30 seconds. When the timing of these measurements coincides with a blood collection, BP 
and pulse rate should be obtained prior to the nominal time of the blood collection.
Additional collection times, or changes to collection times, of BP and pulse rate will be 
permitted, as necessary, to ensure appropriate collection of safety data.
Any untoward vital sign findings that are identified during the active collection period and 
meet the definition of an AE or SAE (Appendix 3) must be reported according to the 
processes in Section 8.4.1 to 8.4.3.
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8.3.3. Electrocardiograms
Single, supine standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) 
should be collected at times specified in the SoA section of this protocol using an ECG 
machine that automatically calculates the HR and measures PR interval, QT interval, QTcF,
and QRS complex. Alternative lead placement methodology using torso leads (eg,
Mason-Likar) should not be used given the potential risk of discrepancies with ECGs 
acquired using standard limb lead placement. All scheduled ECGs should be performed after 
the participant has rested quietly for at least 5 minutes in a supine position.
To ensure safety of the participants, a qualified individual at the investigator site will make 
comparisons to baseline measurements. Additional ECG monitoring will occur if a) a 
post-dose QTcF interval is increased by ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG. If either of these conditions occurs, 
then 2 additional ECGs will be collected approximately 2 to 4 minutes apart to confirm the 
original measurement. If the QTcF values from these repeated ECGs remain above the 
threshold value, then a single ECG must be repeated at least hourly until QTc values from 
2 successive ECGs fall below the threshold value that triggered the repeat measurement.
If a) a post-dose QTcF interval remains ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG for greater than 4 hours (or sooner, at 
the discretion of the investigator); or c) QTcF value get progressively longer, the participant
should undergo continuous ECG monitoring. A cardiologist should be consulted if QTcF
values do not return to less than the criteria listed above after 8 hrs of monitoring (or sooner, 
at the discretion of the investigator).
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine-read QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTcF values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 8.
8.3.4. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol-required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues.
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The investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study in the AE section of the CRF. 
Clinically significant abnormal laboratory test findings are those that are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant’s condition.
All laboratory tests with values considered clinically significant and abnormal during 
participation in the study or within 5 days after the last dose of study intervention should be 
repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or study medical monitor.
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified and the sponsor notified.
See Appendix 6 for suggested actions and follow-up assessments in the event of potential 
DILI.
See Appendix 7 for instructions for laboratory testing to monitor kidney function and 
reporting laboratory test abnormalities.
8.3.5. COVID-19 Specific Assessments
Assessment of risk for, symptoms of or testing for COVID-19 may be performed at 
screening, admission to the CRU and/or at other times during the study at investigator 
discretion and according to local site policies.
8.3.6. Pregnancy Testing
A serum pregnancy test is required in at screening. Following screening, pregnancy tests may 
be urine or serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests 
will be performed in WOCBP at the times listed in the SoA. Following a negative pregnancy 
test result at screening, appropriate contraception must be commenced and a second negative 
pregnancy test result will be required at the baseline visit prior to the participant’s receiving 
the study intervention on Day 1. Pregnancy tests will also be done whenever 1 menstrual 
cycle is missed during the active treatment period (or when potential pregnancy is otherwise 
suspected) and at the end of the study. Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations. If a urine test cannot be confirmed as negative 
(eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant 
must be excluded if the serum pregnancy result is positive.
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 3.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc.).
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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.2).
During the active collection period as described in Section 8.4.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
8.4.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before undergoing any study-related procedure and/or receiving study 
intervention), through and including a minimum of 28 calendar days, except as indicated 
below, after the last administration of the study intervention.
Follow-up by the investigator continues throughout the active collection period and until the 
AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
When a clinically important AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and Pfizer concurs with that assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study because of an AE 
or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the CT 
SAE Report Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider
the event to be reasonably related to the study intervention, the investigator must promptly 
report the SAE to Pfizer using the CT SAE Report Form.
8.4.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.4.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon 
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awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of its being available.
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.4.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE. To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
Reporting of AEs and SAEs for participants who fail screening are subject to the CRF 
requirements as described in Section 5.4.
8.4.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.4.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety.
Further information on follow-up procedures is provided in Appendix 3.
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8.4.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.4.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure, occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include EDP, EDB, and occupational exposure.
Any such exposures to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness.
8.4.5.1. Exposure During Pregnancy
An EDP occurs if:
!
A female participant is found to be pregnant while receiving or after discontinuing 
study intervention;
!
A male participant who is receiving or has discontinued study intervention
inseminates a female partner;
!
A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of environmental exposure. Below are 
examples of environmental EDP:
!
A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by ingestion.
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The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).
!
If EDP occurs in a participant/participant’s partner, the investigator must report this 
information to Pfizer Safety on the CT SAE Report Form and an EDP Supplemental 
Form, regardless of whether an SAE has occurred. Details of the pregnancy will be 
collected after the start of study intervention and until 28 days after the last dose.
!
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental 
Form. Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the 
completed CT SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a liveborn baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs. Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows:
!
Spontaneous abortion including miscarriage and missed abortion should be reported 
as an SAE;
!
Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs. In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention.
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Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.4.5.2. Exposure During Breastfeeding
An EDB occurs if:
!
A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention;
!
A female nonparticipant is found to be breastfeeding while being exposed or having 
been exposed to study intervention (ie, environmental exposure). An example of 
environmental EDB is a female family member or healthcare provider who reports 
that she is breastfeeding after having been exposed to the study intervention by 
ingestion.
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
using the CT SAE Report Form. When EDB occurs in the setting of environmental exposure, 
the exposure information does not pertain to the participant enrolled in the study, so the 
information is not recorded on a CRF. However, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.
An EDB report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (eg, vitamins) is administered in accordance with authorized use. 
However, if the infant experiences an SAE associated with such a drug, the SAE is reported 
together with the EDB.
8.4.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the CT SAE Report Form regardless of 
whether there is an associated SAE. Since the information about the occupational exposure 
does not pertain to a participant enrolled in the study, the information is not recorded on a 
CRF; however, a copy of the completed CT SAE Report Form must be maintained in the 
investigator site file.
8.4.6. Cardiovascular and Death Events
NA.
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8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
NA.
8.4.8. Adverse Events of Special Interest
NA.
8.4.8.1. Lack of Efficacy
This section is not applicable because efficacy is not expected in the study population.
8.4.9. Medical Device Deficiencies
NA.
8.4.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Medication errors are recorded and reported as follows:
Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:
!
Medication errors involving participant exposure to the study intervention;
!
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
In the event of a medication dosing error, the sponsor should be notified within 24 hrs.
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Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
8.5. Pharmacokinetics
8.5.1. Plasma for Analysis of PF-07923568
Blood samples of approximately 2 mL, to provide a minimum volume of 0.8 mL plasma, will
be collected into appropriately labeled tubes containing K2EDTA for measurement of plasma 
concentrations of PF-07923568 as specified in the SoA. Whole blood aliquot (approximately 
0.15 mL) will collected from PK samples for in vivo blood/plasma ratio assessment. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual or by the sponsor. The actual date and time (24-hour clock time) of each 
sample will be recorded.
The actual times may change, but the number of samples will remain the same. All efforts
will be made to obtain the samples at the exact nominal time relative to dosing. Collection of
samples up to and including 10 hours after dose administration that are obtained within
10% of the nominal time relative to dosing (eg, within 6 minutes of a 60-minute sample) will
not be captured as a protocol deviation, as long as the exact time of the collection is noted on
the source document and the CRF. Collection of samples more than 10 hours after dose
administration that are obtained ≤1 hour away from the nominal time relative to dosing will
not be captured as a protocol deviation, as long as the exact time of the collection is noted on
the source document and the CRF.
Samples will be used to evaluate the PK of PF-07923568. Samples collected for analyses of
plasma concentration may also be used to evaluate safety or efficacy aspects related to
concerns arising during or after the study, for metabolite identification and/or evaluation of
the bioanalytical method, or for other internal exploratory purposes.
Genetic analyses will not be performed on these plasma samples unless consent for this was 
included in the informed consent. Participant confidentiality will be maintained.
Samples collected for measurement of plasma concentrations of PF-07923568 will be
analyzed using a validated analytical method in compliance with applicable SOPs. Potential
metabolites may be analyzed with either validated or exploratory methods.
The PK samples must be processed and shipped as indicated in the instructions provided to
the investigator site to maintain sample integrity. Any deviations from the PK sample
handling procedure (eg, sample collection and processing steps, interim storage or shipping
conditions), including any actions taken, must be documented and reported to the sponsor.
On a case-by-case basis, the sponsor may make a determination as to whether sample
integrity has been compromised.
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8.6. Genetics
8.6.1. Specified Genetics
Specified genetic analyses are not evaluated in this study.
8.6.2. Retained Research Samples for Genetics
A 4 mL blood sample optimized for DNA isolation Prep D1 will be collected according to 
the SoA, as local regulations and IRBs/ECs allow.
Retained Research Samples may be used for research related to the study intervention(s) and 
hepatic impairment. Genes and other analytes (eg, proteins, RNA, nondrug metabolites) may 
be studied using the retained samples.
See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment of these samples can be found in the laboratory manual.
8.7. Biomarkers
8.7.1. Specified Gene Expression (RNA) Research
Specified gene expression (RNA) research is not included in this study.
8.7.2. Specified Protein Research
Specified protein research is not included in this study.
8.7.3. Specified Metabolomic Research
Specified metabolomic research is not included in this study.
8.7.4. Retained Research Samples for Biomarkers
These Retained Research Samples will be collected in this study:
!
10 mL whole blood Prep B2 optimized for serum.
Retained Research Samples will be collected as local regulations and IRB/ECs allow 
according to the SoA.
Retained Research Samples may be used for research related to the study intervention(s) and 
hepatic impairment. Genes and other analytes (eg, proteins, RNA, nondrug metabolites) may 
be studied using the retained samples.
See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment of these samples can be found in the laboratory manual and 
supporting documentation. 
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8.8. Immunogenicity Assessments
Immunogenicity assessments are not included in this study.
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the SAP, which will be maintained by the sponsor. 
The SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
No formal statistical hypothesis testing will be performed in this study.
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis 
Set
Description
Enrolled
“Enrolled” means a participant’s, or their legally authorized 
representative’s, agreement to participate in a clinical study 
following completion of the informed consent process and 
assignment to study intervention. A participant will be 
considered enrolled if the informed consent is not withdrawn 
prior to participating in any study activity after screening. 
Potential participants who are screened for the purpose of 
determining eligibility for the study, but do not participate in 
the study, are not considered enrolled, unless otherwise 
specified by the protocol.
Safety analysis set
All participants assigned to study intervention and who take at 
least 1 dose of study intervention.
PK Concentration Set
The PK concentration population is defined as all participants 
who received at least 1 dose of PF-07923568 and in whom at 
least 1 plasma concentration value is reported.
PK Parameter Set
The PK parameter analysis population is defined as all 
participants who received at least 1 dose of PF-07923568 and 
have at least 1 of the PK parameters of interest calculated.
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9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
Endpoints will be reported and analyzed according to the hepatic function group that 
participants fall into based upon their Child-Pugh score at screening.
9.3.1.1. Analyses for PK Endpoints
Natural log-transformed PK parameters (AUCinf, Cmax, and AUClast, as data permit) will be 
analyzed using an ANOVA model including hepatic function group as fixed effect. Estimates 
of the adjusted means and of the adjusted mean differences (Test-Reference) with their 
corresponding 90% CIs will be obtained before being exponentiated to provide estimates of 
the adjusted geometric means and of the ratio of adjusted geometric means (Test/Reference).
9.3.2. Primary Endpoint(s) Analysis
9.3.2.1. Definition of Endpoint(s)
The plasma PK parameters for PF-07923568 following single dose administration will be 
derived from the concentration-time profiles as detailed in Table 4. Actual PK sampling 
times will be used in the derivation of PK parameters. In the case that actual PK sampling 
times are not available, nominal PK sampling time will be used in the derivation of PK 
parameters.
Table 4.
Plasma PK Parameters
Parameter
Definition
Method of Determination
AUClast
Area under the plasma 
concentration-time profile from 
time zero to the time of the last 
quantifiable concentration (Clast)
Linear/Log trapezoidal method.
AUCinf*
Area under the plasma 
concentration-time profile from 
time zero extrapolated to infinite 
time
AUClast + (Clast*/kel), where Clast* is the 
predicted plasma concentration at the last 
quantifiable time point estimated from the 
log-linear regression analysis.
Cmax
Maximum plasma concentration
Observed directly from data.
Tmax
Time for Cmax
Observed directly from data as time of first 
occurrence.
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t1/2*
Terminal half-life
Loge(2)/kel, where kel is the terminal phase 
rate constant calculated by a linear 
regression of the log-linear concentration-
time curve. Only those data points judged to 
describe the terminal log-linear decline will 
be used in the regression.
CL/F*
Apparent clearance
Dose/AUCinf.
Vz/F*
Apparent volume of distribution
Dose/(AUCinf∙kel).
* as data permit
The plasma concentrations of sisunatovir will be listed and descriptively summarized by nominal PK 
sampling time and treatment. Individual participant and summary profiles (mean and median plots) of 
the plasma concentration-time data will be plotted by treatment using actual and nominal times, 
respectively. Mean and median profiles will be presented on both linear and semi-log scales.
Data permitting, the PK parameters listed in Table 4 will be summarized descriptively by treatment.
9.3.2.2. Main Analytical Approach
The effect of varying degrees of hepatic impairment on PK parameters will be assessed by 
constructing 90% CIs around the estimated difference between each of the Test (hepatic 
impaired) groups and the Reference (without hepatic impairment) group. A one-way 
ANOVA will be used to compare the natural log transformed PF-07923568 AUCinf, Cmax, 
and AUClast, as data permit, for each of the hepatic impairment groups (Test) to the group
without hepatic impairment (Reference). Estimates of the adjusted mean differences 
(Test /Reference), and corresponding 90% CIs, will be obtained from the model. These will 
be exponentiated to provide estimates of the ratio of adjusted geometric means 
(Test/Reference) and 90% CIs for the ratios.
Individual PF-07923568 concentrations will be listed and summarized descriptively by 
nominal PK sampling time and hepatic function group. Individual participant and summary 
profiles of the concentration-time data (using actual and nominal times, respectively) will be 
plotted by hepatic function group for total plasma PF-07923568.
Box and whisker plots for individual PK parameters (AUCinf, AUClast, and Cmax, if data 
permit) will be constructed by hepatic function group and overlaid with geometric means. PK 
parameters of PF-07923568 will be summarized descriptively by hepatic function group.  
9.3.2.3. Supplementary Analyses
Additional analysis using linear regression may be used to analyze the potential relationship 
between appropriate PK parameters (eg, AUCinf, AUClast, Cmax, if data permit) and hepatic 
function (eg, serum albumin concentration, PT or T bili). Plots of PK parameters (eg, AUCinf, 
AUClast, Cmax) versus hepatic function will be constructed, with a regression line and 90% 
confidence region included. Estimates of the slope and intercept, together with a 90% CI, and 
the coefficient of determination (ie, R-squared and adj-R-squared) may be obtained from the 
model.
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Additionally, as an exploratory analysis, age and body weight may be explored as additional 
covariates/factors in the models, as appropriate.
9.3.3. Secondary Endpoint Analysis - Safety Analyses
All safety analyses will be performed on the safety population.
AEs, ECGs, BP, pulse rate, and safety laboratory data will be reviewed and summarized on 
an ongoing basis during the study to evaluate the safety of participants. Any clinical 
laboratory, ECG, BP, and pulse rate abnormalities of potential clinical concern will be 
described. Safety data will be presented in tabular and/or graphical format and summarized 
descriptively, where appropriate, following Sponsor standards.
Medical history and PE and neurological examination information, as applicable, collected 
during the course of the study, will be considered source data and will not be required to be 
reported, unless otherwise noted. However, any untoward findings identified on physical 
and/or neurological examinations conducted during the active collection period will be 
captured as AEs, if those findings meet the definition of an AE. Data collected at screening 
that are used for inclusion/exclusion criteria, such as laboratory data, ECGs, and vital signs, 
will be considered source data, and will not be required to be reported, unless otherwise 
noted. Demographic data collected at screening will be reported. COVID-19 specific 
assessments data will be considered source data and will not be required to be reported.
9.3.3.1. Electrocardiogram Analyses
Changes from baseline for the ECG parameters HR, QTcF, PR interval, and QRS complex 
will be summarized by treatment and time. The frequency of uncorrected QT values above 
500 ms will be tabulated.
The number (%) of participants with maximum post-dose QTcF values and maximum 
increases from baseline in the following categories will be tabulated by treatment:
Safety QTcF Assessment
Degree of Prolongation
Mild (ms)
Moderate (ms)
Severe (ms)
Absolute value
>450-480
>480-500
>500
Increase from baseline
30-60
>60
9.3.4. Tertiary/Exploratory Endpoint(s) Analysis
9.3.4.1. Biomarkers
Biomarker data from Retained Research Samples may be collected during or after the trial 
and retained for future analyses; the results of such analyses are not planned to be included in 
the CSR.
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9.3.5. Other Analyses
Pharmacogenomic data from Retained Research Samples may be collected during or after the 
trial and retained for future analyses; the results of such analyses are not planned to be 
included in the CSR.
9.4. Interim Analyses
No formal interim analysis will be conducted for this study. As this is an open-label study,
the sponsor may conduct unblinded reviews of the data during the course of the study for the 
purpose of safety assessment, facilitating PK modeling, and/or supporting clinical 
development.
9.5. Sample Size Determination
A sample size of approximately 28-32 participants (approximately 8 participants per Groups 
1-3, and 4-8 participants in Group 4 based on recruitment rate, with varying degrees of 
hepatic function in each of the 4 Groups) has been selected based on recommendation from 
the “FDA Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic 
Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. Participants 
who discontinue from the study before completing all assessments may be replaced at the 
discretion of the investigator and sponsor.
The expected widths of the 90% CIs with 80% coverage probability are shown in Table 5 for 
a range of possible effects (Test vs Reference). The calculation assumes the selection of the 
default value (80%) of the tolerance parameter in the conventional calculation.8 These 
estimates are based on an assumed conservative standard deviation of 0.6 for logAUCinf (also 
applicable to logCmax) based on data from previous study C5241001 part C, fed condition.
Table 5.
Expected Widths of the 90% CIs (with 80% Coverage Probability) for 
Different Possible Estimated Effects
Estimated ratio 100*
Test/Reference
n=8 per group
AUC
90%CI
CI width
75%
(42.73,131.64)
88.91
100%
(56.97,175.52)
118.55
150%
(85.46,263.28)
177.82
200%
(113.95,351.04)
237.09
400%
(227.89,702.08)
474.19
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:
!
Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;
!
Applicable ICH GCP guidelines;
!
Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:
!
Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;
!
Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;
!
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies, European Medical Device Regulation 2017/745 for 
clinical device research, and all other applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately.
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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
10.1.2. Financial Disclosure
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities.
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant and answer all questions regarding the 
study. The participant should be given sufficient time and opportunity to ask questions and to 
decide whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each participant is fully informed about the nature and 
objectives of the study, the sharing of data related to the study, and possible risks associated 
with participation, including the risks associated with the processing of the participant’s 
personal data.
The participant must be informed that their personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant is fully informed about their 
right to access and correct their personal data and to withdraw consent for the processing of 
their personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
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Participants must be reconsented to the most current version of the IRB/EC-approved ICD(s) 
during their participation in the study as required per local regulations.
A copy of the ICD(s) must be provided to the participant.
Participants who are rescreened are required to sign a new ICD.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to their actual identity and medical record ID. In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains standard operating procedures on how to respond in the event of 
unauthorized access, use, or disclosure of sponsor information or systems.
10.1.5. Committees Structure
A data monitoring committee (DMC) or independent oversight committee (IOC) will not be 
utilized.
10.1.5.1. Data Monitoring Committee
This study will not use an E-DMC.
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10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com 
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized.
Data sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
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Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password-protected or secured in a locked room to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) and 
their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy, including definition of study-critical data items and 
processes (eg, risk-based initiatives in operations and quality, such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
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The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant’s medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
Definition of what constitutes source data and its origin can be found in the Source 
Document Locator, which is maintained by the sponsor.
Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The sponsor or designee will perform monitoring to confirm that data entered into the CRF 
by authorized site personnel are accurate, complete, and verifiable from source documents; 
that the safety and rights of participants are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
10.1.9. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor, including (but not limited to) 
regulatory authority decision, change in opinion of the IRB/EC, or change in benefit-risk 
assessment. Study sites will be closed upon study completion. A study site is considered 
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closed when all required documents and study supplies have been collected and a study -site 
closure visit has been performed.
The investigator may initiate study -site closure at any time upon notification to the sponsor
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:
!
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor’s procedures, or the ICH GCP 
guidelines;
!
Inadequate recruitment of participants by the investigator;
!
Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
For multicenter trials, the primary publication will be a joint publication developed by the 
investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. 
The investigator agrees to refer to the primary publication in any subsequent publications. 
Pfizer will not provide any financial compensation for the investigator’s participation in the 
preparation of the primary congress abstract, poster, presentation, or primary manuscript for 
the study.
Investigators are free to publish individual center results that they deem to be clinically 
meaningful after publication of the overall results of the study or 12 months after primary 
completion date or study completion at all sites, whichever occurs first, subject to the other 
requirements described in this section.
The investigator will provide Pfizer an opportunity to review any proposed publication or 
any other type of disclosure of the study results (collectively, “publication”) before it is 
submitted or otherwise disclosed and will submit all publications to Pfizer 30 days before 
submission. If any patent action is required to protect intellectual property rights, the 
investigator agrees to delay the disclosure for a period not to exceed an additional 60 days 
upon request from Pfizer. This allows Pfizer to protect proprietary information and to provide 
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comments, and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study-intervention or Pfizer-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results. For joint publications, should there be disagreement regarding interpretation 
and/or presentation of specific analysis results, resolution of, and responsibility for, such 
disagreements will be the collective responsibility of all authors of the publication.
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
10.1.11. Sponsor’s Medically Qualified Individual
The contact information for the sponsor’s MQI for the study is documented in the study 
contact list located in the supporting study documentation/study portal or other electronic 
system.
To facilitate access to their investigator and the sponsor’s MQI for study-related medical 
questions or problems from non-study healthcare professionals, participants are provided 
with an ECC at the time of informed consent. The ECC contains, at a minimum, (a) protocol 
and study intervention identifiers, (b) participant’s study identification number, (c) site 
emergency phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center 
number.
The ECC is intended to augment, not replace, the established communication pathways 
between the participant and their investigator and site staff, and between the investigator and 
sponsor study team. The ECC is only to be used by healthcare professionals not involved in 
the research study, as a means of reaching the investigator or site staff related to the care of a 
participant. The Pfizer Call Center number is to be used when the investigator and site staff 
are unavailable. The Pfizer Call Center number is not for use by the participant directly; if a 
participant calls that number directly, they will be directed back to the investigator site.
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10.2. Appendix 2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the SoA section of 
this protocol. Additional laboratory results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laboratory, or as derived 
from calculated values. These additional tests would not require additional collection of 
blood. Unscheduled clinical laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues.
Table 6.
Protocol-Required Safety Laboratory Assessments
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
MCV
MCH
MCHC
Platelet count
WBC count
Total neutrophils 
(Abs)
Eosinophils (Abs)
Monocytes (Abs)
Basophils (Abs)
Lymphocytes (Abs)
Coagulation
aPTT,PT,INR
PT control
BUN
Creatinine (Scr)
Cystatin C (Scys)
eGFRa
Plasma Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Total CO2 (Bicarbonate)
AST
ALT
Alkaline phosphatase
GGT
T bili
Direct bilirubinb,c
Indirect bilirubinb,c
Creatine kinaseb,d
Uric acid
Albumin
Total protein
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte 
esterase
Urobilinogen
Urine bilirubin
Microscopye
Other tests as part of clinical laboratory tests:
At times specified in SoA:
1.
Urine pregnancy test (WOCBP only)f
At screening only:
2.
Serology: HBsAg, HCVAb (if positive,
HCV RNA) and HIV
3.
Serum FSH (all females)
4.
Serum pregnancy test (βhCG) (all females)
5.
Reticulocyte count (Abs)
6.
Total bile acids
7.
Amylase
8.
Lipase
At screening and Day -1 only:
9.
Breath alcohol testg
10. Urine drug testh
For suspected DILI:
11. AST, ALT
12. T bili, direct and indirect bilirubin
13. Total bile acids, GGT
14. Albumin
15. Alkaline phosphatase
16. CK
17. PT, INR
18. Acetaminophen/paracetamol or protein 
adduct levels
For suspected DICI/DIKI:
19. Creatinine (Scr)
20. Cystatin C (Scys)
21. eGFRa
22. Spot (dipstick) UACR
a.
eGFR should be calculated using the 2021 CKD-EPI Scr-Scys combined equations, see Appendix 7.
b.
At screening and Day 1 only, unless conditions for testing are met after Day 1 per notes “c” and “d” below.
c.
After Day 1, direct and indirect bilirubin assessed only when T bili is > ULN.
d.
After Day 1, creatine kinase assessed only when ALT is > ULN.
e.
Only if urine dipstick is positive for blood, protein, nitrites or leukocyte esterase.
f.
Performed on-site using kits approved by sponsor.
g.
Performed on-site using kits approved by sponsor.
h.
Minimum testing requirements include cocaine, THC, opiates and opioids, benzodiazepines and amphetamines.
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF.
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Any remaining serum/plasma from samples collected for clinical safety laboratory 
measurements at baseline and at all times after dose administration may be retained and 
stored for the duration of the study. Upon completion of the study, these retained safety 
samples may be used for the assessment of exploratory safety biomarkers or unexpected 
safety findings. These data will not be included in the CSR. Samples to be used for this 
purpose will be shipped to either a Pfizer approved BBS facility or other designated 
laboratory and retained for up to 1 year following the completion of the study.
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.3.1. Definition of AE
AE Definition
!
An AE is any untoward medical occurrence in a patient or clinical study 
participant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention.
!
Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition
!
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnormal laboratory test 
results that meet any of the conditions below must be recorded as an AE:
!
Is associated with accompanying symptoms;
!
Requires additional diagnostic testing or medical/surgical intervention;
!
Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.
!
Exacerbation of a chronic or intermittent preexisting condition, including an 
increase in either frequency and/or intensity of the condition.
!
New condition detected or diagnosed after study intervention administration, even 
though it may have been present before the start of the study.
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!
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
!
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE or SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae.
Events NOT Meeting the AE Definition
!
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.
!
The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.
!
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is theAE.
!
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
!
Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
10.3.2. Definition of an SAE
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.
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c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
d. Results in persistent or significant disability/incapacity
!
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
!
This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic 
or non-pathogenic
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Pfizer product. The terms “suspected 
transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance 
personnel. Such cases are also considered for reporting as product defects, if 
appropriate.
g. Other situations:
!
Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant 
medical events that may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious.
!
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.
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10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the CT SAE Report Form to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; 
(2) nonserious AEs; and (3) exposure to the study intervention under study during 
pregnancy or breastfeeding, and occupational exposure.
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF. When the same data are collected, the forms must be 
completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding
All AEs/SAEs associated 
with EDP or EDB
Note: Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF
All instances of EDP are 
reported (whether or not 
there is an associated 
SAE)*
All instances of EDB are 
reported (whether or not 
there is an associated 
SAE)**
Environmental or 
occupational exposure to 
the product under study 
to a nonparticipant (not 
involving EDP or EDB)
None. Exposure to a study 
non-participant is not 
collected on the CRF
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
reported***
*
EDP (with or without an associated AE or SAE): any pregnancy information is reported to Pfizer 
Safety using the CT SAE Report Form and EDP Supplemental Form; if the EDP is associated with 
an SAE, then the SAE is reported to Pfizer Safety using the CT SAE Report Form.
** EDB is reported to Pfizer Safety using the CT SAE Report Form, which would also include details 
of any SAE that might be associated with the EDB.
*** Environmental or occupational exposure: AEs or SAEs associated with occupational exposure 
are reported to Pfizer Safety using the CT SAE Report Form.
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!
When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.
!
The investigator will then record all relevant AE or SAE information in the CRF.
!
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE or SAE CRF page.
!
There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.
!
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories:
!
Mild: A type of AE that is usually transient and may require only minimal 
treatment or therapeutic intervention.  The event does not generally interfere with 
usual ADL.
!
Moderate: A type of AE that is usually alleviated with additional specific 
therapeutic intervention. The event interferes with usual ADL, causing discomfort,
but poses no significant or permanent risk of harm to the research participant.
!
Severe: A type of AE that interrupts usual ADL, or significantly affects clinical 
status, or may require intensive therapeutic intervention.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
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Assessment of Causality
!
The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE or SAE. The investigator will use clinical 
judgment to determine the relationship.
!
A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.
!
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated.
!
The investigator will also consult the IB and/or product information, for marketed 
products, in their assessment.
!
For each AE or SAE, the investigator must document in the medical notes that they 
have reviewed the AE or SAE and have provided an assessment of causality.
!
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor.
!
The investigator may change their opinion of causality in light of -follow-up 
information and send an SAE -follow-up report with the updated causality 
assessment.
!
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
!
If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor. In addition, if the investigator determines that 
an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
assessment in the dedicated section of the CT SAE Report Form and in accordance 
with the SAE reporting requirements.
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Follow-Up of AEs and SAEs
!
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.
!
If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings, including histopathology.
!
New or updated information will be recorded in the originally submitted 
documents.
!
The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic DCT
!
The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic DCT.
!
If the electronic system is unavailable, then the site will use the paper SAE DCT
(see next section) to report the event within 24 hours.
!
The site will enter the SAE data into the electronic DCT (eg, eSAE or PSSA) or 
paper form (as applicable) as soon as the data become available.
!
After the study is completed at a given site, the electronic DCT will be taken 
off-line to prevent the entry of new data or changes to existing data.
!
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic DCT has been taken off-line, 
then the site can report this information on a paper SAE form (see next section) or 
to Pfizer Safety by telephone.
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SAE Reporting to Pfizer Safety via the CT SAE Report Form
!
Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.
!
In circumstances when the facsimile is not working, an alternative method should 
be used, eg, secured (Transport Layer Security) or password-protected email. If 
none of these methods can be used, notification by telephone is acceptable with a 
copy of the CT SAE Report Form sent by overnight mail or courier service.
!
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames.
10.4. Appendix 4: Contraceptive and Barrier Guidance
10.4.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 28 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s): 
!
Refrain from donating sperm.
PLUS either:
!
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle 
(abstinent on a longterm and persistent basis) and agree to remain abstinent. 
OR
!
Must agree to use contraception/barrier as detailed below:
!
Agree to use a male condom,and should also be advised of the benefit for a 
female partner to use a highly effective method of contraception, as a condom 
may break or leak, when having sexual intercourse with a WOCBP who is not 
currently pregnant.
!
In addition to male condom use, a highly effective method of contraception may be 
considered in WOCBP partners of male participants (refer to the list of highly 
effective methods below in Section 10.4.4).
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10.4.2. Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion 1 (Age and Sex; Section 5.1) and specify 
the reproductive requirements for including female participants. Refer to Section 10.4.4 for a 
complete list of contraceptive methods permitted in the study.
A female participant is eligible to participate if she (a) is not pregnant or breastfeeding; and
(b) agrees not to donate eggs (ova, oocytes) for the purpose of reproduction at least 35 days 
following the last dose of investigational product; and (c) at least 1 of the following 
conditions applies:
!
Is not a WOCBP (see definition in Section 10.4.3).
OR
!
Is a WOCBP and agrees to use a contraceptive method that is highly effective (failure 
rate of <1% per year) with low user dependency during the intervention period and 
agrees to use it for at least 28 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate any reproductive safety risk of the study 
intervention(s). The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.
OR
!
Is a WOCBP and agrees to use a highly effective (failure rate of <1% per year) 
user-dependent method of contraception during the intervention period and for at 
least 28 days after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention(s). In 
addition to her use of the highly effective method above, she agrees to concurrently
use an effective barrier method. The investigator should evaluate the effectiveness of 
the contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
10.4.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
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Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:
!
Documented hysterectomy;
!
Documented bilateral salpingectomy;
!
Documented bilateral oophorectomy.
For individuals with permanent infertility due to a medical cause other than the above
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied 
to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
2. Postmenopausal female.
!
A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition:
!
A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years old and not using hormonal 
contraception or HRT.
!
A female on HRT and whose menopausal status is in doubt will be required to 
use one of the highly effective non-estrogen hormonal contraception methods 
if she wishes to continue her HRT during the study. Otherwise, she must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrollment.
10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
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3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion.
5. Vasectomized partner.
!
Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the WOCBP and the absence of sperm has 
been confirmed. If not, an additional highly effective method of contraception 
should be used. The spermatogenesis cycle is approximately 90 days.
Highly Effective Methods That Are User Dependent
6. Progestogen-only hormone contraception associated with inhibition of ovulation:
!
Oral + barrier*;
!
Injectable + barrier*.
7. Sexual Abstinence
Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
* Acceptable barrier methods to be used concomitantly with options 6 for the study include 
any of the following:
!
Male or female condom with or without spermicide;
!
Cervical cap, diaphragm, or sponge with spermicide;
!
A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
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10.5. Appendix 5: Genetics
Use/Analysis of DNA
!
Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis.
!
The scope of the genetic research may be narrow (eg, 1 or more candidate genes) or
broad (eg, the entire genome), as appropriate to the scientific question under 
investigation.
!
The samples may be analyzed as part of a multi-study assessment of genetic factors 
involved in the response to study intervention or study interventions of this class to 
understand treatments for the disease(s) under study or the disease(s) themselves.
!
The results of genetic analyses may be reported in the CSR or in a separate study 
summary, or may be used for internal decision making without being included in a 
study report.
!
The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality.
!
The samples will be retained as indicated:
!
Retained samples will be stored indefinitely or for another period as per local 
requirements.
!
Participants may withdraw their consent for the storage and/or use of their Retained 
Research Samples at any time by making a request to the investigator; in this case, 
any remaining material will be destroyed. Data already generated from the samples 
will be retained to protect the integrity of existing analyses.
!
Samples for genetic research will be labeled with a code. The key between the code 
and the participant’s personally identifying information (eg, name, address) will be 
held securely at the study site.
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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations 
(>2 × ULN) by several days or weeks. The increase in T bili typically occurs while 
AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and T bili values will be 
elevated within the same laboratory sample). In rare instances, by the time T bili elevations 
are detected, AST/ALT values might have decreased. This occurrence is still regarded as a 
potential DILI. Therefore, abnormal elevations in either AST OR ALT in addition to T bili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:
!
Participants with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value ≥2 × ULN 
with no evidence of hemolysis and an alkaline phosphatase value <2 × ULN or not 
available.
!
For participants with baseline AST OR ALT OR T bili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
!
Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values ≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN (whichever is 
smaller).
!
Preexisting values of T bili above the normal range: T bili level increased from 
baseline value by an amount of ≥1 × ULN or if the value reaches ≥3 × ULN 
(whichever is smaller).
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Rises in AST/ALT and T bili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment.
In addition to repeating measurements of AST and ALT and T bili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a co-formulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted.
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
T bili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.7. Appendix 7: Kidney Safety: Monitoring Guidelines
10.7.1. Laboratory Assessment of Change in Kidney Function and Detection of Kidney 
Injury
Standard kidney safety monitoring requires assessment of baseline and postbaseline serum 
creatinine(Scr measurement to estimate glomerular filtration rate [Scr-based eGFR] or 
creatinine clearance [eCrCl]). Baseline and postbaseline serum Scys makes it feasible to 
distinguish AKI from other causes of Scr increase. If Scr increase is confirmed after baseline, 
then reflex measurement of Scys is indicated to estimate the combined Scr-Scys eGFR 
calculation (for adults only). In this study, eGFR will be determined using the 2021 
CKD-EPI Scr-Scys combined equation (see Section 10.7.2.1 below) and both Scr and Scys
will be measured as part of the protocol-required safety laboratory assessments at all times 
specified in the SoA.
Regardless of whether kidney function monitoring tests are required as a routine safety 
monitoring procedure in the study, if the investigator or sponsor deems it necessary to further 
assess kidney safety and quantify kidney function, then these test results should be managed 
and followed per standard of care.
10.7.2. Age-Specific Kidney Function Calculation Recommendations
10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI Equations9
2021 CKD-EPI
Scr-Scys 
Combined
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤0.7
if ≤0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if ≤0.7
if >0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.778 × (0.9961)Age
Female
if >0.7
if ≤0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if >0.7
if >0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if ≤0.9
if ≤0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.323 × (0.9961)Age
Male
if ≤0.9
if >0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if >0.9
if ≤0.8
eGFR = 135 × (Scr/0.9)-0.544 × (Scys/0.8)-0.323 × (0.9961)Age
Male
if >0.9
if >0.8
eGFR = 135 × (Scr/0.9)-0.544 × (Scys/0.8)-0.778 × (0.9961)Age
10.7.3. Adverse Event Grading for Kidney Safety Laboratory Abnormalities
AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to KDIGO
criteria.
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Protocol C5241012
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10.8. Appendix 8: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs
!
Marked sinus bradycardia (rate <40 bpm) lasting minutes.
!
New PR interval prolongation >280 ms.
!
New prolongation of QTcF to >480 ms (absolute) or by ≥60 ms from baseline.
!
New-onset atrial flutter or fibrillation, with controlled ventricular response rate: 
ie, rate <120 bpm.
!
New-onset type I second-degree (Wenckebach) AV block of >30 seconds’
duration.
!
Frequent PVCs, triplets, or short intervals (<30 seconds) of consecutive ventricular 
complexes.
ECG Findings That May Qualify as SAEs
!
QTcF prolongation >500 ms.
!
New ST-T changes suggestive of myocardial ischemia.
!
New-onset LBBB (QRS complex>120 ms).
!
Newonset right bundle branch block (QRS complex>120 ms).
!
Symptomatic bradycardia.
!
Asystole:
!
In awake, symptom-free participants in sinus rhythm, with documented periods 
of asystole ≥3.0 seconds or any escape rate <40 bpm, or with an escape rhythm 
that is below the AV node.
!
In awake, symptom-free participants with atrial fibrillation and bradycardia 
with 1 or more pauses of at least 5 seconds or longer.
!
Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.
!
Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute).
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!
Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm (HR
<40 bpm), accelerated idioventricular rhythm (HR >40 bpm to <100 bpm), and 
monomorphic/polymorphic ventricular tachycardia (HR >100 bpm [such as
torsades de pointes]).
!
Type II second-degree (Mobitz II) AV block.
!
Complete (third-degree) heart block.
ECG Findings That Qualify as SAEs
!
Change in pattern suggestive of new myocardial infarction.
!
Sustained ventricular tachyarrhythmias (>30 seconds’ duration).
!
Second- or third-degree AV block requiring pacemaker placement.
!
Asystolic pauses requiring pacemaker placement.
!
Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.
!
Ventricular fibrillation/flutter.
!
At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and Pfizer study team, and not to be 
considered as all-inclusive of what to be reported as AEs/SAEs.
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Protocol C5241012
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Page 90
10.9. Appendix 9: Prohibited Concomitant Medications That May Result in Drug-Drug 
Interaction (DDI)
The prohibited concomitant medications listed below should not be taken with PF-07923568 
for the period of time at least equal to 5 half-lives plus 14 days preceding the first dose of 
study intervention, and throughout the conduct of the study.
The Pfizer study team is to be notified of any prohibited medications taken during the study. 
After consulting with the sponsor, the investigator will make a judgment on the ongoing 
participation of any participant with prohibited medication use during the study.
This list of drugs prohibited for potential DDI concerns with the IMP may be revised during 
the course of the study with written notification from sponsor, to include or exclude specific 
drugs or drug categories for various reasons (eg, emerging DDI results for the IMP, 
availability of new information in literature on the DDI potential of other drugs).
Strong and moderate CYP3A4 and P-gp inhibitors or inducers are prohibited, as these 
medications may have meaningful impact on the pharmacokinetics of sisunatovir.
PF-07923568 is a CYP3A4 inhibitor and therefore sensitive and narrow therapeutic index 
CYP3A4 substrates are also prohibited in this study. Since based on in vitro data 
PF-07923568 may be a weak inhibitor of CYP2B6, sensitive narrow TI substrates of 
CYP2B6 are excluded.
PF-07923568 also may be an inhibitor of OCT1 and MATE1 transporters; therefore, 
sensitive substrates of these transporters are excluded.
Although his is not all-inclusive, a list of medications that are prohibited in this study is 
provided below. Site staff should consult with the sponsor or designee with any questions 
regarding potential DDI.
Investigators should consult the product label for any other medication used during the study 
for information regarding medication that is prohibited for concomitant use.
Prohibited Concomitant Medications
CYP3A Inhibitors
CYP3A Inducers
Moderate
Strong
Moderate
Strong
Aprepitant
Boceprevir
Bosentan
Apalutamide
Ciprofloxacin
Cobicistat
Efavirenz
Carbamazepine
Conivaptan
Danoprevir
Etravirine
Enzalutamide
Crizotinib
Dasabuvir
Phenobarbital
Mitotane
Cyclosporine
Elvitegravir
Primidone
Phenytoin
Diltiazem
Indinavir
Rifampin
Dronedarone
Itraconazole
St. John’s wort
Erythromycin
Ketoconazole
Fluconazole
Lopinavir
Fluvoxamine
Paritaprevir
Imatinib
Ombitasvir
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Tofisopam
Posaconazole
Verapamil
Ritonavir
Saquinavir
Telaprevir
Tipranavir
Telithromycin
Troleandomycin
Voriconazole
Sensitive CYP3A Substrates
CYP3A Substrates 
with Narrow Therapeutic Index
Alfentanil
Lovastatin
Alfentanil
Atorvastatin
Lurasidone
Astemizole
Avanafil
Maraviroc
Cisapride
Budesonide
Midazolam
Cyclosporine
Buspirone
Naloxegol
Dihydroergotamine
Darifenacin
Nisoldipine
Ergotamine
Darunavir
Quetiapine
Fentanyl
Dasatinib
Sildenafil
Pimozide
Dronedarone
Simvastatin
Quinidine
Ebastine
Sirolimus
Sirolimus
Eletriptan
Tacrolimus
Tacrolimus
Eplerenone
Ticagrelor
Terfenadine
Everolimus
Tolvaptan
Ibrutinib
Tipranavir
Indinavir
Triazolam
Felodipine
Vardenafil
Lomitapide
Sensitive MATE1 Substrates
Metformin
Sensitive CYP2B6 Substrates
CYP2B6 Substrates 
with Narrow Therapeutic Index
Velpatasvir
Cyclophosphamide
P-gp Inhibitors
P-gp Inducers
Atazanavir
Lopinavir
Apalutamide
Boceprevir
Lumacaftor
Atazanavir
Cobicistat
Mifepristone
Fosamprenavir
Conivaptan
Nelfinavir
Lopinavir
Cyclosporine
ombitasvir and paritaprevir 
and ritonavir and dasabuvir
Rifampin
Darunavir
Posaconazole
St. John’s wort (hypericum perforatum) extract
Diltiazem
Ritonavir
Tipranavir
elvitegravir and cobicistat 
and emtricitabine and 
tenofovir DF
Saquinavir
Verapamil
Erythromycin
Telaprevir
glecaprevir and pibrentasvir
Tipranavir
Indinavir
Tucatinib
Itraconazole
Verapamil
Ketoconazole
vonoprazan and amoxicillin 
and clarithromycin
Lonafarnib
Voxilaprevir
Sensitive OCT Substrates
Imatinib 
Not an all-inclusive list.
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10.10. Appendix 10: Child-Pugh Classification of Liver Dysfunction
Table 7.
Scoring for Child-Pugh Classification10
Group
Child-Pugh 
Score
Level of 
Dysfunction
Total Score
(tally based on assessment of 
parameters in Table 8)
1
Not Applicable
Without hepatic 
impairment
Not Applicable
2
A
Mild
5-6
3
B
Moderate
7-9
4
C
Severe
≥10
Table 8.
Derivation of Child-Pugh Classification Score
Assessment Parameters
Assigned score for observed findings
1 point
2 points
3 points
Encephalopathy gradea
(refer to Table 9 below)
0
1 or 2
3 or 4a
Ascites
Absent
Asymptomatic
Requiring intervention
Serum T bili, mg/dL
<2
2 to 3
>3
Serum albumin, g/dL
>3.5
2.8 to 3.5
<2.8
PT, sec prolonged
<4
4 to 6
>6
a.
Participants with a prior history of Grade 3 or 4 encephalopathy who are currently receiving 
an intervention [eg, lactulose or lactitol, alone or in combination with rifaximin, and/or neomycin] to 
manage encephalopathy related signs and symptoms should be scored for encephalopathy grading based 
on their presentation while on intervention at the screening visit and can be included in Study C5241012
as long as they do not have clinically active Grade 3 or 4 encephalopathy.
Table 9.
Determination of Encephalopathy Grade
Encephalopathy Grade
Definition
0
Normal consciousness, personality, neurological exam
1
Restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting
2
Lethargic, time-disoriented, inappropriate, asterixis, ataxia
3a
Somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity
4a
Unrousable coma, no personality/behavior, decerebrate
a.
Participants with clinically active Grade 3 or 4 encephalopathy are excluded.
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Protocol C5241012
Final Protocol, 23 February 2023
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10.11. Appendix 11: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
Abs
absolute
ADL
activity/activities of daily living
AE
adverse event
AKI
acute kidney injury
ALP
alkaline phosphatase
ALT
alanine aminotransferase
ANOVA
analysis of variance
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUC12
area under the plasma concentration-time profile over 12 hrs
AUC24
area under the plasma concentration-time profile over 24 hrs
AUCinf
area under the plasma concentration-time profile from time zero 
extrapolated to infinite time
AUClast
area under the plasma concentration-time profile from time zero to 
the time of the last quantifiable concentration
AUCtau
area under the plasma concentration-time profile over tau, the 
dosing interval, where tau = 24 hours
AV
atrioventricular
AxMP
auxiliary medicinal product
#-hCG
#-human chorionic gonadotropin
BBS
Biospecimen Banking System
BID
twice daily
BMI
body mass index
BP
blood pressure
bpm
beats per minute
BUN
blood urea nitrogen
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CKD-EPI
chronic kidney disease epidemiology
CL
total clearance of drug from eg, plasma
CL/F
apparent clearance of drug from eg, plasma
Clast
last quantifiable concentration
Cmax
maximum plasma concentration
CO2
carbon dioxide (bicarbonate)
COVID-19
coronavirus disease 2019
CPC
Child-Pugh Classification
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Abbreviation
Term
CRF
case report form
CRO
contract research organization
CRU
clinical research unit
CSR
Clinical Study Report
CT
clinical trial
CTIS
Clinical Trial Information System
CT scan
computed tomography scan
CV
cardiovascular
CYP
cytochrome P450
DBP
diastolic blood pressure
DCT
data collection tool
DDI
drug-drug interaction
DIC
Drug in Capsule
DICI
drug-induced creatinine increase
DIKI
drug-induced kidney injury
DILI
drug-induced liver injury
DPB
Dry Powder Blend
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram or electrocardiography
eCrCl
estimated creatinine clearance
eCRF
electronic case report form
EDB
exposure during breastfeeding
E-DMC
External Data Monitoring Committee
EDP
exposure during pregnancy
eGFR
estimated glomerular filtration rate
eSAE
electronic serious adverse event
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials 
(European Clinical Trials Database)
FIH
first-in-human
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GI
gastrointestinal
H
hour
HAE
hypoglycemic adverse event
HBsAg
hepatitis B surface antigen
HCVAb
hepatitis C antibody
HI
hepatic impairment
HIV
human immunodeficiency virus
HR
heart rate
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Page 95
Abbreviation
Term
hrs
hours
HRT
hormone replacement therapy
IB
Investigator’s Brochure
ICD
informed consent document
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
ID
identification
ICU
intensive care unit
IMP
investigational medicinal product
IND
Investigational New Drug
INR
international normalized ratio
IPAL
Investigational Product Accountability Log
IPM
investigational product manual
IRB
Institutional Review Board
IV
intravenous(ly)
K2EDTA
dipotassium ethylene diamine tetraacetic acid
kel
first-order elimination rate constant
KDIGO
Kidney Disease Improving Global Outcomes
LBBB
left bundle branch block
LFT
liver function test
LRTI
lower respiratory tract infection
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
MCV
mean corpuscular volume
MAD
multiple ascending dose
MATE1
multidrug and toxin exclusion protein 1
MQI
medically qualified individual
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
NA
Not Applicable
NIMP
noninvestigational medicinal product
NOAEL
no observed adverse effect level
OAT
organic anion transporter
OATP
organic anion transporting polypeptide
OCT
octamer binding transcription factor
PD
pharmacodynamic(s)
PE
physical examination
P-gp
P glycoprotein
PK
pharmacokinetic(s)
PSSA
Pfizer's Serious Adverse Event Submission Assistant
PT
prothrombin time
PVC
premature ventricular contraction/complex
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Abbreviation
Term
QTc
corrected QT interval
QTcF
QTc corrected using Fridericia’s formula
qual
qualitative
RBC
red blood cell
RSV CV
respiratory syncytial virus challenge virus
SAD
single ascending dose
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SBP
systolic blood pressure
Scr
serum creatinine
Scys
serum cystatin C
SoA
schedule of activities
SOC
System Organ Class
SOP
standard operating procedure
SRSD
Single Reference Safety Document
SSID
single subject identifier
SUSAR
Suspected Unexpected Serious Adverse Reaction
t½
terminal phase half-life
T bili
total bilirubin
TEAE
treatment-emergent adverse event
THC
tetrahydrocannabinol
TI
therapeutic index
Tmax
time to reach Cmax
UACR
urine albumin/creatinine ratio
ULN
upper limit of normal
US
United States
VS
vital signs
Vz/F
apparent volume of distribution
WBC
white blood cell
WOCBP
woman/women of childbearing potential
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P F -0 7 9 2 3 5 6 8
Pr ot oc ol C 5 2 4 1 0 1 2
Fi nal Pr ot oc ol, 2 3 Fe br uar y 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical P har mac ol o g y Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 7
1 1. R E F E R E N C E S
1.
F D A. G ui da nce f or i n d ustr y : p har mac o ki netics i n patie nts wit h i m paire d he patic 
f u ncti o n: st u d y desi g n, data a nalys is, a n d i m pact o n d osi n g a n d la beli n g . Ma y 2 0 0 3. 
Accesse d: 1 4 Fe b 2 0 2 3.
2.
Si m oes E A F, B o nt L, Ma nz o ni P, et al. Past, Prese nt a n d f ut ure a p pr oac hes t o t he 
pre ve nti o n a n d treat me nt of res pirat or y sy n c ytial vir us i nfecti o n i n c hil dre n . I nfect Dis 
T her. 2 0 1 8; 7( 1): 8 7 - 1 2 0.
3.
Li Y , Wa n g X, Bla u D M, et al. Gl o bal, re gi o nal, a n d nati o nal disease b ur de n esti mates 
of ac ute l o wer res pirat or y i nfecti o ns d ue t o res pirat or y s y n c ytial vir us i n c hil dre n 
y o u n ger t ha n 5 y ears i n 2 0 1 9: a s yste matic a nalys is. La ncet. 2 0 2 2; 3 9 9( 1 0 3 4 0): 2 0 4 7 - 6 4.
4.
R ha B, C ur ns A T, Li vel y J Y, et al. Res pirat or y s ync y tial vir us-ass ociate d 
h os pitalizati o ns a m o n g y o u n g c hil dre n : 2 0 1 5-2 0 1 6. Pe diatrics. 2 0 2 0; 1 4 6( 1).
5.
La n gle y  J M, Bia nc o V, D o mac h o ws ke J B, et al. I nci de nce of res pirat or y s yn c y tial vir us 
l o wer res pirat or y tract i nfecti o ns d uri n g t he first 2 ye ars of life: a pr os pecti ve st u d y 
acr oss di verse gl o bal setti n gs . J Infect Dis. 2 0 2 2; 2 2 6( 3): 3 7 4 - 8 5.
6.
J ha A, Jar vis H, Fraser C, et al. Res pirat or y s yn c y tial vir us. In: H ui D S, R ossi G A, 
J o h nst o n S L, e ds. S A R S, M E R S a n d ot her Viral L u n g I nfecti o ns. S heffiel d ( U K) 2 0 1 6.
7.
Ki m L , R ha B, A bra ms o n J S, et al. Ide ntif y i n g ga ps i n res pirat or y sy nc yt ial vir us 
disease e pi de mi ol o g y  i n t he U nite d States pri or t o t he i ntr o d ucti o n of vacci nes . Cli n 
I nfect Dis. 2 0 1 7; 6 5( 6): 1 0 2 0- 5.
8.
Pfizer. 
. Sa m ple size calc ulati o n: cr oss-o ver trials t o 
de m o nstrate bi oe q ui vale nce or esti mate bi oa vaila bilit y . Cli nical bi ostatistics tec h nical 
re p ort # 5. 1 ( Versi o n Date: A pril 2 4, 2 0 0 2).
9.
I n ker L A, E nea n ya N D, C ores h J , et al. Ne w creati ni ne- a n d c ys tati n C- base d eq uati o ns 
t o esti mate G F R wit h o ut race. N E n gl J Me d. 2 0 2 1; 3 8 5: 1 7 3 7 - 4 9.
1 0.
P u g h R N, M urra y -L y o n I M, Da ws o n J L,  et al. Tra nsecti o n of t he oes o p ha g us f or 
blee di n g oes o p ha geal varices. Br J S ur g. 1 9 7 3; 6 0( 8): 6 4 6 - 9.
0 9 0 1 7 7 e 1 9 c b 7 8 5 b 2\ A p pr o v e d\ A p pr o v e d O n: 2 4- F e b- 2 0 2 3 0 2: 2 3 ( G M T)
P P D

SAP_001.pdf: 
Protocol C5241012 (PF-07923568) Statistical Analysis Plan
DMB02-GSOP-RF02 7.0 Statistical Analysis Plan Template 31-Jan-2022
PFIZER CONFIDENTIAL  
TMF Doc ID: 98.03
Page 1 of 17
Protocol C5241012
A Phase 1, open-label, single-dose, parallel group study to compare the pharmacokinetics 
and safety of PF-07923568 in adult participants with varying degrees of hepatic 
impairment relative to participants without hepatic impairment
Statistical Analysis Plan 
(SAP)
Version: 
1.0 
Author:  
Date:  
19 May 2023
090177e19da34f08\Final\Final On: 03-Jun-2023 23:20 (GMT)
PPD


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090177e19da34f08\Final\Final On: 03-Jun-2023 23:20 (GMT)


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090177e19da34f08\Final\Final On: 03-Jun-2023 23:20 (GMT)


Pr ot oc ol C 5 2 4 1 0 1 2  (P F -0 7 9 2 3 5 6 8 ) Statistical A nal ysis Pla n  
 
D M B 0 2 -G S O P -R F 0 2 7. 0 St atistic al A n alysis Pl a n Te m pl ate  3 1 -Ja n-2 0 2 2  
P FI Z E R  C O N FI D E N TI A L   
T M F D oc I D: 9 8. 0 3  
Pa ge 4 of 1 7  
N O T E :  It alicize d te xt wit hi n t his d oc u me nt has bee n ta ke n ver bati m fr o m t he Pr ot oc ol. 
1.  V E R SI O N  HI S T O R Y  
T a ble 1.  
S u m m ar y of C h a n ges   
Versi o n / 
D ate  
Ass oci ate d 
Pr ot oc ol 
A m e n d m e nt  
R ati o n ale  
S pecific C h a n ges  
1 /  
1 9  Ma y 2 0 2 3   
Ori gi nal  
2 3  Fe b  2 0 2 3  
N/ A  
N/ A  
 
2.  I N T R O D U C TI O N 
P F - 0 7 9 2 3 5 6 8 (sis u n at ovir) is bei n g devel o pe d t o a ct as a hi g hly p ote nt, selective, or ally 
av ail a ble a ge nt t o tre at a n d preve nt R S V i nfecti o n. P F - 0 7 9 2 3 5 6 8 is a n i n hi bit or of  
 
 t h at is c urre ntly bei n g i nvesti g ate d f or t he tre at me nt of 
R S V i nfecti o n.  
 
T he pri m ary p ur p ose of t his st u dy is t o c h ar acterize t he effect of v ar yi n g de grees of HI o n t h e 
pl as m a P K of P F- 0 7 9 2 3 5 6 8 f oll o wi n g a d mi nistr ati o n of a si n gle or al d ose of P F- 0 7 9 2 3 5 6 8. 
T his statistical a nal ysis pla n (S A P ) pr o vi des t he d etaile d met h o d ol o g y f or s u m mar y a n d 
statistical a nal yses of t he data c ollecte d i n St u d y C 5 2 4 1 0 1 2. 
2. 1.  M o dific ati o ns t o t he A n al ysis Pl a n Descri be d  i n t he Pr ot oc ol 
N o ne. 
0 9 0 1 7 7 e 1 9 d a 3 4f 0 8\ Fi n al\ Fi n al O n: 0 3- J u n- 2 0 2 3 2 3: 2 0 ( G M T)
C CI


Pr ot oc ol C 5 2 4 1 0 1 2  (P F -0 7 9 2 3 5 6 8 ) Statistical A nal ysis Pla n  
 
D M B 0 2 -G S O P -R F 0 2 7. 0 St atistic al A n alysis Pl a n Te m pl ate  3 1 -Ja n-2 0 2 2  
P FI Z E R  C O N FI D E N TI A L   
T M F D oc I D: 9 8. 0 3  
Pa ge 5 of 1 7  
2. 2.  St u d y O bjecti ves  a n d E n d p oi nts  
O bjectives  
E n d p oi nts  
Pri m ary:  
Pri m ary:  
•  T o c o m p are t he P K of P F -0 7 9 2 3 5 6 8 
f oll o wi n g a d mi nistr ati o n of a si n gle or al 
d ose i n a d ult p artici p a nts wit h v aryi n g 
de grees of HI r el ative t o a ge- a n d b o dy 
wei g ht -m atc he d p artici p a nts wit h o ut HI.  
•  Pl as m a: C m ax ,  A U Cl ast or A U C i nf*, as d at a 
per mit.  
Sec o n d ary:  
Sec o n d ary:  
•  T o ev al u ate t he s afety a n d t oler a bility of a 
si n gle or al d ose of P F- 0 7 9 2 3 5 6 8 w he n 
a d mi nistere d t o a d ult p artici p a nts wit h 
v aryi n g de grees of HI a n d i n a ge- a n d 
b o dy wei g ht- m atc he d p artici p a nts wit h o ut 
HI.  
•  Assess me nt of T E A Es, cli nic al l a b or at ory 
a b n or m alities, V S, E C G p ar a meters. 
Ot her:  
Ot her:  
•  T o c o m p are a d diti o n al P K p ar a meters of 
P F - 0 7 9 2 3 5 6 8 f oll o wi n g a d mi nistr ati o n of 
a si n gle or al d ose i n a d ult p artici p a nts 
wit h v aryi n g de grees of HI a n d i n a ge- 
a n d b o dy wei g ht- m atc he d p artici p a nts 
wit h o ut HI.  
•  Pl as m a: C L/ F, V z/ F, Tm ax  a n d t 1/ 2 as d at a 
per mit.  
* A U C l ast will b e tre ate d as pri m ary e n d p oi nts if d at a d o n ot p er mit r o b ust esti m ati o n of A U C i nf, ot h er wise t h ey will be 
tre ate d as terti ary e n d p oi nts. 
 
2. 3.  St u d y Desi g n  
T his is a n o pe n -l a bel, si n gle-d ose, p ar allel -gr o u p, m ultice nter st u dy t o i nvesti g ate t he effect of 
v aryi n g de grees of he p atic f u ncti o n o n t he pl as m a  P K of P F -0 7 9 2 3 5 6 8 after a si n gle, or al 
m g d ose  a d mi nistere d i n t he fe d st ate (st a n d ar d bre akf ast). A t ot al of a p pr oxi m ately 2 8-
3 4 p artic i p a nts wit h v aryi n g de grees of he p atic f u ncti o n will be a d mi nistere d as a si n gle, or al 
m g d ose of P F- 0 7 9 2 3 5 6 8 i n t he fe d st ate as s h o w n i n T a ble 2. 
 
 
0 9 0 1 7 7 e 1 9 d a 3 4f 0 8\ Fi n al\ Fi n al O n: 0 3- J u n- 2 0 2 3 2 3: 2 0 ( G M T)
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090177e19da34f08\Final\Final On: 03-Jun-2023 23:20 (GMT)


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090177e19da34f08\Final\Final On: 03-Jun-2023 23:20 (GMT)