A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Phase: PHASE1
Conditions: Healthy Volunteers
Sponsor: Takeda

NCT Number: NCT05382104
Title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect 
of Food on Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Study Number: TAK-620-1025
Document Version and Date: Original Version (27-April-2022)
Certain information within this document has been redacted (ie, specific content is masked 
irreversibly from view) to protect either personally identifiable information or company 
confidential information. 
Clinical Study Protocol
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TAKEDA PHARMACEUTICALS
PROTOCOL
A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on 
Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Study Identifier:
TAK-620-1025
Compound:
Maribavir (TAK-620)
Date:
27 April 2022
Version/Amendment 
Number:
Initial version
CONFIDENTIAL PROPERTY OF TAKEDA
This document is a confidential communication of Takeda. Acceptance of this document constitutes the agreement 
by the recipient that no information contained herein will be published or disclosed without written authorization 
from Takeda except to the extent necessary to obtain informed consent from those persons to whom the drug may be 
administered. Furthermore, the information is only meant for review and compliance by the recipient, his or her 
staff, and applicable institutional review committee and regulatory agencies to enable conduct of the study.
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27 April 2022
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TABLE OF CONTENTS
LIST OF IN-TEXT TABLES ..........................................................................................................7
LIST OF APPENDICES..................................................................................................................7
1.0
STUDY SUMMARY...........................................................................................................8
2.0
STUDY SCHEMATIC ......................................................................................................13
3.0
SCHEDULE OF STUDY PROCEDURES .......................................................................14
4.0
INTRODUCTION .............................................................................................................16
4.1
Background..................................................................................................................16
4.2
Rationale for the Proposed Study ................................................................................19
4.3
Benefit-Risk Profile .....................................................................................................20
5.0
STUDY OBJECTIVES AND ENDPOINTS.....................................................................21
5.1
Hypothesis....................................................................................................................21
5.2
Study Objectives ..........................................................................................................21
5.2.1
Study Primary Objectives ......................................................................................21
5.2.2
Study Secondary Objective....................................................................................21
5.2.3
Study Exploratory Objective..................................................................................21
5.3
Endpoints .....................................................................................................................21
5.3.1
Primary Endpoints .................................................................................................21
5.3.2
Secondary Endpoints .............................................................................................22
5.3.3
Exploratory Endpoints ...........................................................................................22
6.0
STUDY DESIGN AND DESCRIPTION..........................................................................23
6.1
Study Design................................................................................................................23
6.2
Dose Escalation............................................................................................................23
6.3
Stopping Rules.............................................................................................................23
6.4
Rationale for Study Design, Dose, and Endpoints.......................................................23
6.4.1
Rationale of Study Design .....................................................................................23
6.4.2
Rationale for Dose .................................................................................................24
6.4.3
Rationale for Endpoints .........................................................................................24
6.4.3.1
Pharmacokinetic Endpoints.........................................................................24
6.4.3.2
Safety Endpoints .........................................................................................24
6.4.4
Critical Procedures Based on Study Objectives: Timing of Procedures................24
6.5
Study Design/Dosing/Procedures Modifications Permitted Within Protocol 
Parameters....................................................................................................................24
6.6
Study Beginning and End/Completion ........................................................................24
6.6.1
Definition of Beginning of the Study.....................................................................24
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6.6.2
Definition of End of the Study...............................................................................25
6.6.3
Definition of Study Completion.............................................................................25
6.6.4
Definition of Study Discontinuation......................................................................25
6.6.5
Criteria for Premature Termination or Suspension of the Study ...........................25
6.6.6
Criteria for Premature Termination or Suspension of a Site..................................25
7.0
SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS......26
7.1
Inclusion Criteria .........................................................................................................26
7.2
Exclusion Criteria ........................................................................................................26
7.3
Excluded Medications, Supplements, Dietary Products..............................................28
7.4
Diet, Fluid, Activity.....................................................................................................29
7.4.1
Diet and Fluid ........................................................................................................29
7.4.2
Activity ..................................................................................................................30
7.5
Criteria for Discontinuation or Withdrawal of a Participant .......................................30
7.6
Procedures for Discontinuation or Withdrawal of a Participant..................................32
7.7
Participant Replacement ..............................................................................................32
8.0
CLINICAL STUDY MATERIAL MANAGEMENT.......................................................33
8.1
Clinical Investigational Drug.......................................................................................33
8.1.1
Clinical Investigational Drug Labeling..................................................................33
8.1.2
Clinical Investigational Drug Inventory and Storage ............................................33
8.1.3
Clinical Investigational Drug Blinding..................................................................33
8.1.4
Randomization Code Creation and Storage...........................................................33
8.1.5
Clinical Study Blind Maintenance/Unblinding Procedure ....................................34
8.1.6
Accountability and Destruction of Sponsor-Supplied Drugs.................................34
9.0
STUDY PROCEDURES ...................................................................................................35
9.1
Administrative Procedures...........................................................................................35
9.1.1
Informed Consent Procedure .................................................................................35
9.1.1.1
Assignment of Screening and Randomization Numbers ............................35
9.1.1.2
Investigational Drug Assignment................................................................35
9.1.2
Inclusion and Exclusion.........................................................................................35
9.1.3
Medical History/Demography ...............................................................................35
9.1.4
Concomitant Medications......................................................................................35
9.2
Clinical Procedures and Assessments..........................................................................35
9.2.1
Full Physical Examination.....................................................................................36
9.2.2
Height and Weight .................................................................................................36
9.2.3
BMI........................................................................................................................36
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9.2.4
Vital Signs..............................................................................................................36
9.2.5
12-Lead ECG .........................................................................................................36
9.2.6
Investigational Drug Administration .....................................................................37
9.2.7
AE Monitoring.......................................................................................................37
9.2.8
Laboratory Procedures and Assessments...............................................................37
9.2.8.1
Clinical Laboratory Tests............................................................................38
9.3
PK Samples..................................................................................................................39
9.3.1
PK Measurements ..................................................................................................39
9.3.1.1
Plasma for PK Measurements.....................................................................40
9.3.2
Biomarker Measurements......................................................................................41
9.3.3
PGx Measurements................................................................................................41
9.3.4
Confinement...........................................................................................................41
10.0
ADVERSE EVENTS.........................................................................................................42
10.1
Definitions and Elements of AEs.................................................................................42
10.1.1 SAEs 44
10.1.2 Adverse Events of Special Interest ........................................................................45
10.2
AE Procedures .............................................................................................................45
10.2.1 Assigning Severity/Intensity of AEs......................................................................45
10.2.2 Assigning Causality of AEs...................................................................................45
10.2.3 Start Date ...............................................................................................................46
10.2.4 End Date.................................................................................................................46
10.2.5 Pattern of Adverse Event (Frequency)...................................................................46
10.2.6 Action Taken With Study Treatment.....................................................................46
10.2.7 Outcome.................................................................................................................47
10.2.8 Collection and Reporting of AEs, SAEs, Special Interest AEs, and Abnormal 
Liver Function Tests (LFTs)..................................................................................47
10.2.8.1
Collection Period.........................................................................................47
10.2.8.2
Reporting AEs.............................................................................................47
10.2.8.3
Reporting SAEs...........................................................................................48
10.2.8.4
Reporting Special Interest AEs...................................................................49
10.2.8.5
Reporting of Abnormal LFTs .....................................................................49
10.2.9 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities .....49
11.0
STATISTICAL METHODS..............................................................................................51
11.1
Statistical and Analytical Plans....................................................................................51
11.1.1 Analysis Sets..........................................................................................................51
11.1.1.1
PK Set .........................................................................................................51
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11.1.1.2
Safety Set ....................................................................................................51
11.1.2 Analysis of Demography and Other Baseline Characteristics...............................51
11.1.3 PK Analysis ...........................................................................................................51
11.1.3.1
Food-effect estimation ................................................................................52
11.1.3.2
Non-Parametric Analysis ............................................................................52
11.1.3.3
Exploratory Analysis...................................................................................52
11.1.4 Pharmacodynamic Analysis...................................................................................52
11.1.5 Safety Analysis ......................................................................................................52
11.1.5.1
AEs..............................................................................................................52
11.1.5.2
Clinical Laboratory Evaluation...................................................................53
11.1.5.3
Vital Signs...................................................................................................53
11.1.5.4
Other Safety Parameters..............................................................................53
11.2
Interim Analysis and Criteria for Early Termination...................................................53
11.3
Determination of Sample Size .....................................................................................54
12.0
QUALITY CONTROL AND QUALITY ASSURANCE.................................................55
12.1
Study-Site Monitoring Visits.......................................................................................55
12.2
Protocol Deviations......................................................................................................55
12.3
Quality Assurance Audits and Regulatory Agency Inspections..................................55
13.0
ETHICAL ASPECTS OF THE STUDY...........................................................................57
13.1
IRB and/or IEC Approval............................................................................................57
13.2
Participant Information, Informed Consent, and Participant Authorization................58
13.3
Participant Confidentiality...........................................................................................59
13.4
Publication, Disclosure, and Clinical Study Registration Policy.................................59
13.4.1 Publication and Disclosure ....................................................................................59
13.4.2 Clinical Study Registration....................................................................................60
13.4.3 Clinical Study Results Disclosure..........................................................................60
13.5
Insurance and Compensation for Injury.......................................................................60
14.0
ADMINISTRATIVE AND REFERENCE INFORMATION...........................................61
14.1
Administrative Information .........................................................................................61
14.1.1 Study Contact Information.....................................................................................61
14.1.2 Investigator Agreement..........................................................................................62
14.1.3 Study-Related Responsibilities..............................................................................63
14.1.4 List of Abbreviations .............................................................................................63
15.0
DATA HANDLING AND RECORDKEEPING ..............................................................65
15.1
CRFs (Electronic and Paper) .......................................................................................65
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15.2
Record Retention .........................................................................................................65
16.0
REFERENCES ..................................................................................................................67
17.0
APPENDICES ...................................................................................................................69
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LIST OF IN-TEXT TABLES
Table 2.a
Study Schematic.....................................................................................................13
Table 2.b
Study Treatments for Study Investigational Drug .................................................13
Table 4.a
Statistical Analysis of the Pharmacokinetic Parameters of Maribavir 
Following a Single Oral Dose of 400 mg Maribavir Tablet II Under Fed and 
Fasted Conditions (Study 1263-104) .....................................................................17
Table 4.b
Statistical Analysis of the Pharmacokinetic Parameters of Maribavir 
Following a Single Oral Dose of 400 mg Maribavir Capsules Under Fed and 
Fasted Conditions (Study CMAB1002).................................................................18
Table 7.a
Excluded Medications, Supplements, and Dietary Products .................................29
Table 7.b
Examples of Low-Fat/Low-Calorie and High-Fat/High-Calorie Meals and 
Breakdown of Calories and Contents ....................................................................30
Table 8.a
Randomization Sequence.......................................................................................34
Table 9.a
Primary Specimen Collections...............................................................................39
Table 9.b
Sampling Collection Window................................................................................39
LIST OF APPENDICES
Appendix A
Responsibilities of the Investigator........................................................................69
Appendix B
Elements of the Participant Informed Consent ......................................................71
Appendix C
Investigator Consent to the Use of Personal Information......................................74
Appendix D
Pregnancy and Contraception ................................................................................75
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1.0
STUDY SUMMARY
Name of Sponsor:
Takeda Development Center Americas, Inc. (TDCA)
95 Hayden Avenue
Lexington, MA 02421
Telephone: +1 (617) 679-7000
Compound:
Maribavir (TAK-620)
Study Identifier: TAK-620-1025
Phase: 1
Protocol Title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on 
Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Study Design:
This is a single-center, open-label, single-dose, randomized, 3-period, 6-sequence, crossover study in healthy 
adult participants.
Study schematic and dose regimens are shown in Table 2.a and Table 2.b. The schedule of assessments is shown 
in Schedule of Study Procedures (Section 3.0).
A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be administered orally under 
3 different feeding conditions:
1)
Fasting (Treatment A),
2)
Fed following a low-fat/low-calorie meal (Treatment B), and
3)
Fed following a high-fat/high-calorie meal (Treatment C).
There will be a washout period of a minimum of 72 hours between each investigational drug (ID) dosing.
Pharmacokinetic (PK) sample collections will be conducted predose and up to 36 hours postdose in each 
treatment period.
Safety and tolerability will be assessed throughout the study by treatment-emergent adverse events (TEAEs), 
vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
The clinical research unit (CRU) will contact all participants (including participants who terminate the study 
early) 7 (±4) days after the last ID administration by telephone or other methods per CRU standards to determine 
if any adverse event (AE) has occurred or concomitant medications have been taken since the last study visit. If 
clinically significant findings are observed upon discharge, participants may return to the CRU for re-evaluation 
per Investigator’s discretion.
Study Primary Objectives:
To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet 
formulation administered with a low-fat/low-calorie meal relative to administration under fasting conditions.
To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet 
formulation administered with a high-fat/high calorie meal relative to administration under fasting conditions.
Study Secondary Objective:
To evaluate the safety and tolerability of a single oral dose of 400 mg maribavir commercial (marketed) tablet 
formulation when administered under fasting conditions, with a low-fat/low-calorie meal and with a 
high-fat/high-calorie meal.
Study Exploratory Objective:
To evaluate other PK parameters of a single oral dose of 400 mg maribavir commercial (marketed) tablet 
formulation when administered under fasting conditions, with a low-fat/low-calorie meal and with a 
high-fat/high-calorie meal.
Study Participant Population: Healthy male and female participants aged 19 to 55 years inclusive with a Body 
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Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at the screening visit.
Planned Number of Participants:
Thirty (30) participants will be enrolled.
Planned Number of Sites:
1
Dose Level:
400 mg (2 x 200 mg) commercial (marketed) tablet
Route of Administration:
Oral
Duration of Treatment:
Single-dose
Planned Study Duration:
Approximately 42 days including screening period of up 
to 28 days and follow-up.
Criteria for Inclusion:
Participants must fulfill the following inclusion criteria before the first dose of the ID to be eligible for 
participation in the study:
1.
An understanding, ability, and willingness to fully comply with study procedures and restrictions. 
2.
Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized 
representative) informed consent to participate in the study.
3.
Age 19-55 years, inclusive at the time of consent, at the screening visit. The date of signature of the 
informed consent is defined as the beginning of the screening period. 
4.
Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive 
requirements of the protocol or female of non-childbearing potential. Additional details are outlined in 
Appendix D.
5.
Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical 
history. Healthy status is defined by absence of evidence of any active or chronic disease following a 
detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, 
hematology, blood chemistry (includes thyroid stimulating hormone [TSH] and free thyroxine [FT4] at the 
screening visit), and urinalysis.
6.
Hemoglobin for males 135.0 g/L and females 120.0 g/L at the screening visit and on Day -1 of Treatment 
Period 1.
7.
BMI between 18.0 and 30.0 kg/m2, inclusive with a body weight >50 kg (110 lbs), at the screening visit.
8.
Ability to swallow a dose of the ID.
Criteria for Exclusion:
Participants must not be enrolled in the study if they meet any of the following criteria before the first dose of the 
ID:
1.
History or presence of gastritis, gastrointestinal (GI) tract, hepatic disorder or cholecystectomy, history of 
treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the opinion of the 
Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the ID.
2.
History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, 
gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of 
the ID, or clinical or laboratory assessments.
3.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment 
or make the participant unlikely to fully complete the study, or any condition that presents undue risk from 
the ID or procedures.
4.
Known or suspected intolerance or hypersensitivity to the ID, closely related compounds, or any of the 
stated ingredients and excipients.
5.
Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the ID.
6.
Has diarrhea within 4 hours of the first dose of the ID.
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7.
Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose 
of the ID.
8.
Within 30 days prior to the first dose of the ID:
Have used any investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
Have been enrolled in a clinical study (including vaccine studies) that, in the Investigator or designee’s 
opinion, may impact this Takeda-sponsored study.
Have had any substantial changes in eating habits, as assessed by the Investigator or designee.
9.
Systolic blood pressure >140 mmHg or <90 mmHg, and diastolic blood pressure >90 mmHg or <50 mmHg, 
at the screening visit.
10. Twelve-lead ECG demonstrating corrected QT interval (QTc) >450 msec at the screening visit. If QTc 
exceeds 450 msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be 
used to determine the participant’s eligibility.
11. Known history of alcohol or other substance abuse within the last year.
12. Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female 
participants who consume more than 14 units of alcohol per week or 2 units per day (1 alcohol unit=1 beer 
or 1 wine [5 oz/150 mL] or 1 liquor [1.5 oz/40 mL] or 0.75 oz alcohol).
13. A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of Treatment Period 1. 
Urine samples are to be tested for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, 
methadone, opiates, and phencyclidine.
14. A positive human immunodeficiency virus (HIV), hepatitis B surface antibody (HBsAg), or hepatitis C virus 
(HCV) antibody screen at the screening visit.
15. Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, 
gum, patch). Ex-users must self-report that they have stopped using tobacco for at least 3 months prior to 
receiving the first dose of the ID.
16. Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine 
withdrawal headaches (1 caffeine unit is contained in the following items: one 6 oz [180 mL] cup of coffee, 
two 12 oz [360 mL] cans of cola, one 12 oz cup of tea, three 1 oz [85 g] chocolate bars). Decaffeinated 
coffee, tea, or cola are not considered to contain caffeine.
17. Current use of any prescription medication with the exception of hormonal contraceptives and hormonal 
replacement therapy. Current use is defined as use within 30 days of the first dose of the ID. Current use of 
any over-the-counter medication (including over-the-counter multi-vitamin, herbal, or homeopathic 
preparations) within 14 days of the first dose of the ID. Hormonal contraceptives (refer to Appendix D) and 
hormonal replacement therapy may be permitted if the participant has been on the same stable dose for at 
least 3 months prior to first dose of the ID. Appropriate sources (eg, Flockhart TableTM) will be consulted to 
confirm lack of PK/pharmacodynamic interaction with the ID. 
18. Current use of antacids, proton pump inhibitors, or H2 antagonists within 14 days of the first dose of the ID.
19. Inability or unwillingness to consume 100 percent of high-fat meal or low-fat meal (including participants 
with lactose or gluten intolerance).
20. Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal reflux, asthma 
treatment with albuterol, or zinc supplementation.
21. Participants with dry mouth syndrome or burning mouth syndrome or participants suffering from dysgeusia.
Main Criteria for Evaluation and Analyses:
Primary Endpoints:
The following PK parameters in plasma will be analyzed for maribavir:

Maximum observed concentration (Cmax)
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
Area under the concentration-time curve from time 0 to the time of the last quantifiable 
concentration (AUClast)

Area under the concentration-time curve from time 0 to infinity, calculated using the observed 
value of the last quantifiable concentration (AUC∞)
Secondary Endpoints:

TEAEs and their number, severity, seriousness, and causality 

Changes in vital signs, ECGs, and clinical laboratory results (hematology, chemistry, and 
urinalysis) from baseline to post-baseline time points, and evaluation of clinical signs.
Exploratory Endpoints:
Exploratory PK endpoints include (if applicable, but are not limited to) additional PK parameters for maribavir 
as follows:

Concentration at 12 hours postdose (C12)

Area under the concentration-time curve from time 0 to 12 (AUC12)

Time to first occurrence of Cmax (tmax)

Area under the curve from the last quantifiable concentration to infinity, calculated using the 
observed value of the last quantifiable concentration, expressed as a percentage of AUC∞ 
(AUCextrap%)

Terminal disposition phase rate constant (λz)

Terminal disposition phase half-life (t½z)

Apparent volume of distribution during the terminal disposition phase after oral administration, 
calculated using the observed value of the last quantifiable concentration (Vz/F)

Apparent clearance after oral administration, calculated using the observed value of the last 
quantifiable concentration (CL/F)

Lag time to first quantifiable concentration in plasma (tlag)
Statistical Considerations:
Pharmacokinetic analysis:
Individual maribavir plasma concentrations and PK parameters will be listed by participant and treatment, and 
summarized by treatment (maribavir plasma concentrations and PK parameters) and nominal time (maribavir 
plasma concentrations).
PK parameters (Cmax, AUClast, AUC∞, AUC12, AUCextrap%, C12, tmax, λz, t½z, CL/F, Vz/F, and tlag) will be computed 
using standard non-compartmental analysis (NCA). Actual time of sampling will be used to calculate the PK 
parameters. The PK endpoints will be presented descriptively. All individual concentration data and PK 
parameters will be listed with summary statistics such as geometric mean, median, arithmetic mean, standard 
deviation (SD), coefficient of variation (CV), minimum and maximum. Individual plasma concentration/time 
curves will be presented in linear/linear and log/linear scale. At least 3 PK time points within the terminal 
log-linear phase will be used to estimate the terminal rate constant for each participant in each treatment period.
The appropriate PK analysis will be fully specified in the Clinical Pharmacology Analysis Plan (CPAP).
Estimation of food-effect:
A mixed-effect model will be applied to log-transformed Cmax, AUClast, and AUC∞with treatment, period, and 
sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their 
associated 90% confidence intervals (CIs) will be constructed for the differences between Treatment B 
(low-fat/low-calorie meal) versus Treatment A (fasting), and Treatment C (high-fat/high-calorie meal) versus 
Treatment A (fasting). The point estimates and their associated 90% CIs will be then back transformed to 
provide point estimates and 90% CIs for the ratios of Treatment B (low-fat/low-calorie meal) versus 
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Treatment A (fasting) and Treatment C (high-fat/high-calorie meal) versus Treatment A (fasting). 
Analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed Rank test.
Safety analysis:
The safety data will be summarized descriptively for TEAEs, and potentially clinically significant values for 
clinical laboratory tests, vital signs, 12-lead ECG, and use of concomitant medications by treatment. Baseline 
will be the last assessment before the first dose of the ID. TEAEs are defined as those with a start date on or after 
the first dose of the ID, or with a start date before the date of first dose of the ID but increasing in severity after 
the first dose of the ID.
Exploratory analysis:
In a separate analysis, both non-compartmental and compartmental PK modeling will be used to project the 
steady-state AUC12, Cmax and C12 after theoretical regimens of multiple twice daily (BID) oral doses of 400 mg 
maribavir commercial (marketed) formulation under different dosing conditions (Treatment A, B, or C). The 
results from this analysis will not be listed in the clinical study report (CSR) and will be detailed in a separate 
report.
Additional exploratory analyses may be conducted and reported separately.
Sample Size Justification:
Thirty (30) participants will be enrolled to account for possible dropouts.
A total of 24 participants should complete all treatment periods of the study.
Sample size calculations is performed using R package PowerTOST and were based on the following:

The intra-participant CV was assumed at 0.166 and 0.218, respectively for AUC∞and Cmax, which were 
estimated from the 90% CIs of the geometric mean ratio (GMR) of AUC∞, and Cmax in Study 1263-104.

Reference data set is AUC∞or Cmax under fasting conditions; test data set is AUC∞or Cmax under fed 
conditions

Assumed GMR for Test / Reference: 0.80, 0.85, 0.90, 0.95, or 1.00

The estimated 90% CIs of the GMRs at 0.90, with N = 24, is within (0.80, 1.25) for both AUC∞and 
Cmax.
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2.0
STUDY SCHEMATIC
Table 2.a
Study Schematic
Pretreatment
Predose 
Assessments
Treatment Periods 1-2-3 (a)
Study Exit
Follow-up (b)
Screening
Check-in
Dosing and Safety 
and PK Assessments
Safety and PK 
Assessments
Day 2 of 
Treatment 
Period 3
7 (±4) days 
after last dose
Day -28 to 
first dosing of 
ID
Day -1 of 
Treatment 
Period 1
Day 1
Day 2
Confinement (c) 
(a) There will be a washout period of a minimum of 72 hours between each ID dosing.
(b) The CRU will contact all participants (including participants who terminate the study early) 7 (± 4) days after the 
last ID administration by telephone or other methods per CRU standards to determine if any AE has occurred or 
concomitant medications have been taken since the last study visit. If clinically significant findings are observed 
upon discharge, participants may return to the CRU for re-evaluation per Investigator’s discretion.
(c) Participants will start the confinement on Day -1 of Treatment Period 1 and will remain confined until Day 2 of 
Treatment Period 3. Participants may be admitted earlier for Coronavirus disease 2019 (COVID-19) testing not 
related to study protocol as per CRU requirements. 
Table 2.b
Study Treatments for Study Investigational Drug
Treatment
Investigational Drug
Dose
Dose Regimen
Days on 
Investigational Drug
Treatment A
Maribavir commercial 
(marketed) tablet 
formulation
400 mg (2 x 200-mg)
Single dose, oral, fast 
Day 1
Treatment B
Maribavir commercial 
(marketed) tablet 
formulation
400 mg (2 x 200-mg)
Single dose, oral, fed: 
following a low-
fat/low-calorie meal
Day 1
Treatment C
Maribavir commercial 
(marketed) tablet 
formulation
400 mg (2 x 200-mg)
Single dose, oral, fed: 
following a 
high-fat/high-calorie 
meal
Day 1
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3.0
SCHEDULE OF STUDY PROCEDURES
Study Procedures a
S b
Treatment 
Period 1 
Only
Study Days in Each Treatment Period c
EOP3 
or ET d
FU e
Days →
-1
1
2
2
Hours →
C-I f
0
0.25
0.5
1
1.5
2
3
3.5
4
5
6
8
12
16 g
24
36
Administrative Procedures
Informed Consent
X
Inclusion/Exclusion Criteria
X
X
Medical History
X
Safety Evaluations 
Physical Examination
X
X
Height
X
Weight
X
X
X
Vital Signs (PR and BP)
X
X h
X
X
Vital Signs (T and RR)
X
X
12-Lead Safety ECG
X
X h
X k
X
X
Hem, Serum Chem i, and UA 
X
X
X j
X k
X l
FT4 and TSH
X
Serum Pregnancy Test (♀only)
X
X
X j
Serum FSH (PMP ♀only)
X
Urine Drug and Alcohol Screen
X
X
HIV/Hepatitis Screen
X
AE Monitoring
X
<----------------------------------------------------------------------X------------------------------------------------------------------------>
X
ConMeds Monitoring
X
<----------------------------------------------------------------------X------------------------------------------------------------------------>
ID Administration / PK
Maribavir Administration
X m
Blood for Maribavir PK
X n
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Other Procedures
Confinement in the CRU f
<----------------------------------------------------------------------X------------------------------------------------------------------------>
Visit 
X
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a.
The study procedures will be detailed in Section 9.0.
b.
Screening will start within 28 days prior to the first ID administration on Day 1 of Treatment Period 1.
c.
There will be a washout period of a minimum of 72 hours between each ID dosing.
d.
To be performed at the end of Treatment Period 3 or prior to early termination from the study.
e.
The CRU will contact all participants (including participants who terminate the study early) 7 (± 4) days after the last ID administration by telephone or 
other methods per CRU standards to determine if any AE has occurred or concomitant medications have been taken since the last study visit. If clinically 
significant findings are observed upon discharge, participants may return to the CRU for re-evaluation per Investigator’s discretion.
f.
Participants will be admitted to the CRU on Day -1 of Treatment Period 1, at the time indicated by the CRU, until completion of study procedures on Day 
2 of Treatment Period 3. Participants may be admitted earlier than Day -1 for COVID-19 testing not related to study protocol, as per CRU requirements.
g.
The 16-hour postdose time point will be either on Day 1 or Day 2, depending on the time of dosing on Day 1.
h.
To be performed within 2 hours prior to the ID dosing.
i.
Samples for serum clinical chemistry will be obtained following a fast of at least 8 hours, however, in case of dropouts or rechecks, participants may not 
have fasted for 8 hours prior to the serum chemistry sample is taken.
j.
To be performed prior to the ID dosing, in Treatment Period 2 and Treatment Period 3 only.
k.
To be performed in Treatment Period 3 only.
l.
To be performed at early termination only, if termination was due to any AE.
m. In Treatment A, participants will be dosed fasted. In Treatments B and C, participants will receive a meal 30 minutes prior to dosing the ID; the meal will 
be entirely consumed within 30 minutes.
n.
To be performed prior to the ID dosing.
Abbreviations: ♀= Females, AE = Adverse events, BP = Blood pressure, C-I = Check-in, Chem = Chemistry, ConMeds = Concomitant medication, 
COVID-19 = Coronavirus disease 2010, CRU = Clinical research unit, ECG = Electrocardiogram, EOP3 or ET = End of Treatment Period 3 or early termination, 
FSH = Follicle-stimulating hormone, FT4 = Free thyroxine, FU = Follow-up, Hem = Hematology, HIV = Human immunodeficiency virus, ID = Investigational 
drug, PK = Pharmacokinetics, PMP = Premenopausal, PR = Pulse rate, RR = Respiration rate, S = Screening, T = Temperature, TSH = Thyroid stimulating 
hormone, UA = Urinalysis.
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4.0
INTRODUCTION
4.1
Background
Maribavir is a potent and selective, orally bioavailable antiviral drug with a novel mechanism of 
action against cytomegalovirus (CMV) [1] and a favorable non-clinical and clinical safety 
profile. It is a potent member of a new class of drugs, the benzimidazole ribosides [2]. In 
side-by-side in vitro assays, it is 3- to 20-fold more potent than ganciclovir and cidofovir and at 
least 100-fold more potent than foscarnet [3-4]. Unlike currently available anti-CMV agents that 
inhibit CMV deoxyribonucleic acid (DNA) polymerase, maribavir inhibits viral DNA assembly 
and also inhibits egress of viral capsids from the nucleus of infected cells [2-7]. In both in vitro 
and in vivo studies, strains of CMV resistant to ganciclovir, foscarnet, or cidofovir, or resistant to 
combinations of these drugs, remained sensitive to maribavir.
LIVTENCITY (maribavir) is approved by the United States (US) Food and Drug Administration 
(FDA) for the treatment of adults and pediatric patients (12 years of age and older and weighing 
at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or 
without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet; the 
approved dosing regimen is 400 mg twice daily [8]. Prior to maribavir, no therapies were 
approved for the treatment of CMV infection or CMV disease in transplant recipients nor for 
CMV infection or disease that is resistant or refractory to currently available therapies. 
Maribavir’s clinical efficacy has been demonstrated in two Phase 2 dose ranging clinical trials in 
adults and one Phase 3 clinical trial for the treatment of CMV infection or disease in transplant 
recipients, including those infections resistant or refractory to ganciclovir, valganciclovir, 
foscarnet, or cidofovir.
Previous Clinical Studies on the Effect of Food on Maribavir
Various maribavir solid oral formulations (capsule and tablet formulations I, II, III and IV) have 
been used in several Phase 1 studies over the course of maribavir clinical development. Tablet II 
was used in the dose-ranging Phase 2 studies, while Tablet IV was used in the pivotal Phase 3 
studies. Tablet I and Tablet II were bioequivalent (Study 1263-104). Based on the cross-study 
analysis of data from studies 1263-104 and TAK-620-1019 which compared Tablet II and 
Tablet IV maribavir formulations following single dose administration, maribavir AUCs were 
similar, however relative bioavailability data have not been generated. Tablet II used unmilled 
maribavir drug substance while Tablet IV used milled particles. Two clinical studies were 
conducted to evaluate the food effects with varying fat content on the PK and relative 
bioavailability of maribavir after single oral administration of the Tablet II (Study 1263-104) and 
capsule formulations (Study CMAB1002). No food effect study has been performed with 
maribavir Tablet IV and commercial formulation.
Study 1263-104 was an open-label, single-dose, randomized, three-way crossover study in 
healthy male and female adult participants to evaluate the relative bioavailability of maribavir 
Tablet II relative to maribavir Tablet I and the effect of food on the bioavailability of the 
maribavir Tablet II (Study 1263-104 CSR and Goldwater et al., 2009 [9]).
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Randomly assigned participants to 1 of 6 treatment sequence groups (5 participants per 
sequence) received the following 3 treatments (A, B, and C): maribavir 400 mg (4×100 mg) 
Tablet I - “fasted” (Treatment A); maribavir 400 mg (2×200 mg) Tablet II –“fasted” 
(Treatment B); and maribavir 400 mg (2×200 mg) Tablet II-“fed” (Treatment C; in the original 
clinical study report for Study 1263-104, the meal was referred to as “moderately high-fat 
breakfast”). Treatment A and B were received after overnight fast, while Treatment C was 
received after moderate fat breakfast. The treatments were separated by a 1-week washout 
period.
Out of 30 enrolled participants 28 participants completed all 3 treatments in this study. Blood 
samples for maribavir PK assessment were collected up to 24 hours postdose. Maribavir PK 
parameters for participants who received a single oral dose of maribavir 400 mg (Tablet II) under 
fed (moderate-fat breakfast) and fasted conditions are presented in Table 4.a. When maribavir 
Tablet II was administered with food, median tmax was prolonged from 1.5 hours to 2 hours, and 
Cmax decreased 28%. However, the AUClast and AUC∞values, although 14% lower with food, 
were considered equivalent (90% CI within the 0.80 to 1.25 no-effect range).
Table 4.a
Statistical Analysis of the Pharmacokinetic Parameters of Maribavir 
Following a Single Oral Dose of 400 mg Maribavir Tablet II Under Fed 
and Fasted Conditions (Study 1263-104)
Parameter
Tablet II Fed (N=29)
Tablet II Fasted 
(N=29)
Tablet II Fed / Tablet II Fasteda 
(90% CI) (N=28)
AUClast (µg*h/mL)b
81.6
95.0
0.860 (0.802, 0.922)
AUC∞(µg*h/mL)b
85.6
99.0
0.864 (0.804, 0.929)
Cmax (µg/mL)b
11.4
15.9
0.722 (0.656, 0.793)
tmax (h)c
2.0 (1.0, 4.0)
1.5 (1.0, 4.0)
N/Ad
ANOVA=analysis of variance; AUC=area under the plasma concentration-versus-time curve from time 0 to the last 
measurable concentration (AUClast) and from time 0 to infinity (AUC∞); CI=confidence interval; Cmax=maximum measured 
plasma concentration; N/A=not applicable; tmax=time to Cmax
a Least squares geometric mean ratio.
b Geometric mean.
c Median (minimum, maximum).
d The p-value for the ranked values of tmax from the ANOVA model was <0.001.
Source: Study 1263-104 CSR, Table 10.2.3.2, Table 10.2.3.3, and Table 10.2.3.4.
In summary, based on a modest decrease in Cmax and no effect on AUC, controlling the timing of 
low-fat breakfast intake with respect to oral administration of maribavir Tablet II is not needed.
Study CMAB1002 was a single-dose, double-blind, randomized, placebo-controlled, 
dose-escalation study conducted in HIV-infected adult male participants (Study CMAB1002 
CSR and Wang et al., 2003 [10]). During the initial 4 treatment periods, each participant 
received under fasted conditions 3 escalating single doses of maribavir capsules (100, 400, 800, 
or 1600 mg, administered as 100 mg capsules) and 1 dose of matching placebo, according to a 
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randomized assignment to treatment sequence. A minimum 5-day washout period separated each 
treatment period. To evaluate the effect of food on the PK of maribavir, participants who 
received maribavir 400 mg in Period 2 were to receive an additional 400 mg maribavir 
dose following consumption of a high-fat breakfast during a fifth (fed) treatment period. 
Participants assigned to placebo in Period 2 were not studied during the fifth period. Blood and 
urine PK samples were collected through 24 hours postdose.
Seventeen (17) participants were enrolled in the study. Thirteen (13) participants received 
maribavir 400 mg in a fasted condition and 10 of these 13 participants received maribavir 
400 mg in a fed condition. Maribavir PK parameters following oral administration of 400 mg 
maribavir under fed and fasted conditions are presented in Table 4.b.
Table 4.b
Statistical Analysis of the Pharmacokinetic Parameters of Maribavir 
Following a Single Oral Dose of 400 mg Maribavir Capsules Under Fed 
and Fasted Conditions (Study CMAB1002)
Parameter
Maribavir 400 mg 
Fed (N=10)
Maribavir 400 mg 
Fasted (N=13)
Maribavir 400 mg Fed/Fasted a
(90% CI) (N=13)
AUClast (µg*h/mL)b
52.01
69.99
0.734 (0.588, 0.917)
AUC∞(µg*h/mL)b
53.09
71.85
0.729 (0.579, 0.918)
Cmax (µg/mL)b
11.41
16.11
0.715, (0.609, 0.840)
tmax (h)c
3.5 (1.5, 5.0)
1.5 (1.0, 2.0)
N/Ad
ANOVA=analysis of variance; AUC=area under the plasma concentration-versus-time curve from time 0 to the last 
measurable concentration (AUClast) and from time 0 to infinity (AUC∞); CI=confidence interval; Cmax=maximum measured 
plasma concentration; N/A=not applicable; tmax=time to Cmax
a Least squares geometric mean ratio.
b Geometric mean.
c Median (minimum, maximum).
d The p-value for the ranked values of tmax from the ANOVA model was 0.0015.
Note: The maribavir 100 mg capsule formulation was used in this study.
Source: Study CMAB1002 CSR, Table 10.2.11.2, Table 10.2.11.5, Table 10.2.11.6, and Table 10.2.11.7.
In summary, administration of maribavir capsules in HIV-infected adult participants following 
consumption of a standard high-fat breakfast delayed plasma total maribavir tmax by 
approximately 2 hours and plasma maribavir AUC∞and Cmax decreased by 27% and 28%, 
respectively.
Safety Profile
Maribavir has been administered across a broad range of oral doses from 50 to 2400 mg/day. 
Clinical safety data has been obtained from 18 Phase 1 studies in adult healthy volunteers, 
special populations (participants with renal and hepatic impairment, and stable renal transplant 
recipients), and HIV-infected participants. No death or other serious adverse events (SAEs) was 
reported for any participants in a Phase 1 study with maribavir. The most common TEAE in 
single- and multiple-dose Phase 1 studies was taste disturbance (dysgeusia). ECG, vital signs, 
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and laboratory findings did not suggest any treatment-emergent abnormalities related to 
maribavir. A definitive QT study demonstrated no clinically significant repolarization effect of 
maribavir administered orally at single doses of 100 mg and 1200 mg in healthy participants. In 
addition, no other significant ECG effects of maribavir were found. Maribavir (400 mg BID) was 
shown to increase the whole blood trough concentration of tacrolimus by 57% in a clinical drug 
interaction study. 
Initially developed for prophylaxes against CMV, maribavir had a favorable safety and 
tolerability profile in both the Phase 2 and Phase 3 trials for CMV prophylaxes. Most frequent 
TEAEs that appeared to be associated with maribavir were GI AE (eg, diarrhea, dysgeusia, 
nausea, and vomiting). These events were generally of mild or moderate intensity. There were no 
signals of clinically significant effects of maribavir on vital signs, ECG parameters, or laboratory
findings in the studies conducted for CMV prophylaxis.
In two Phase 2 studies for CMV infection treatment (Studies SHP620-202 and SHP620-203) 
maribavir was well-tolerated with no safety concerns at all doses evaluated, ie, 400, 800, or 
1200 mg BID. In Study SHP620-202, the most frequent TEAEs (occurred in ≥20% of maribavir-
treated participants) were dysgeusia, followed by nausea, vomiting, diarrhea, fatigue, and 
anemia. In Study SHP620-203, the most frequent TEAEs (occurred in ≥20% of maribavir-treated 
participants) were dysgeusia, followed by nausea, diarrhea and vomiting. Analyses of clinical 
laboratory, vital signs, and ECG data did not identify any clinically meaningful differences 
across the maribavir treatment groups.
In a pivotal Phase 3 study for CMV treatment (SHP620303), maribavir 400 mg BID was well 
tolerated and safe. Dysgeusia was the most frequently reported TEAE overall. Other frequently 
reported TEAEs greater than 10% included nausea, diarrhea, vomiting, fatigue, and pyrexia. In 
Study SHP620-303, the TEAE of immunosuppressant drug level increased was reported in 
21 participants in the maribavir group (9.0%).
To date, maribavir has shown an overall favorable safety profile in placebo-controlled studies, 
open-label studies, and in studies that compared maribavir with other CMV therapies 
(ganciclovir, valganciclovir) for prophylaxis and for CMV treatment in hematopoietic stem-cell 
transplant and solid organ transplant recipients.
Refer to the latest version of the maribavir Investigator’s Brochure for the most detailed and 
most current information regarding the drug metabolism, PK, efficacy, and safety of maribavir.
4.2
Rationale for the Proposed Study
At the end-of-phase-2 meeting with Japan’s Pharmaceuticals and Medical Devices Agency
(PMDA), PMDA requested a definitive food effect study be conducted with the commercial 
formulation of maribavir. High-fat/high-calorie meal typically elicits the most pronounced food 
effect on orally administered drugs and therefore is assessed in the food effect study, per 
recommendation of regulatory agencies. In addition, transplant recipients are often on a low-fat 
For non-commercial use only
SHP620
HP62
doses ev
doses 
TEAEs 
TEAE
usea, vom
ea, vo
TEAEs (
EAEs
ea, diarrh
a, diar
t identify
denti
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eatme
s the mo
the m
0% incl
0% in
AE of im
AE of 
r g

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diet. Therefore, the purpose of this study is to investigate the effect of food on maribavir PK 
administered as the commercial tablet formulation in healthy adult human participants under 
different food conditions. Thus, maribavir PK under three different food conditions will be 
evaluated: 
•Fasted (Treatment A)
•Fed following a low-fat/low-calorie meal as defined by the FDA (Treatment B)
•Fed following a high-fat/high-calorie meal as defined by the FDA (Treatment C)
The low-fat/low-calorie meal should contain in total 400-500 kCal with 100-125 kCal from fat. 
“The low-fat meal” per the FDA draft guidance (Guideline for Assessing the Effects of Food on 
Drugs in INDs and NDAs — Clinical Pharmacology Considerations) is referred to as “moderate 
meal” in the European Medicines Agency (EMA) guidance document (EMA Guideline on the 
Investigations of Drug Interactions) and as “low-fat diet” in the Japan’s PMDA guidance 
(Guideline for Bioequivalence Studies of Generic Products) [11-13]. The fat content and total 
calorie counts are consistent in these three guidance documents. For the sake of consistency, this 
meal is referred to in this protocol as the “low-fat/low-calorie meal.”
The high-fat/high-calorie meal should contain in total 800-1000 kCal with 500-600 kCal from 
fat, 250 kCal from carbohydrates, and 150 kCal from proteins (The FDA-recommended high-fat 
meal is generally consistent with the standardized high-fat meal recommended by the 
EMA/Committee for Medicinal Products for Human Use guideline [11-12]. Food effect studies 
conducted with the standard high-fat, high-calorie meal that conforms to FDA or EMA guidance 
are generally deemed acceptable by Japan PMDA.
4.3
Benefit-Risk Profile
Maribavir will be administered at the dose according to the product label and the adult dosing 
recommendations found therein [8].
There will be no direct health benefit for study participants from receipt of the ID. An indirect 
health benefit to the healthy participants enrolled in this study is the free medical tests performed 
at screening and during the study.
The inclusion and exclusion criteria, screening, and safety monitoring practices employed by this 
protocol (ie, 12-lead ECG, vital signs, clinical laboratory tests, AE questioning, and physical 
examination) are adequate to protect the participant’s safety.
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5.0
STUDY OBJECTIVES AND ENDPOINTS
5.1
Hypothesis
Not applicable.
5.2
Study Objectives
5.2.1
Study Primary Objectives
To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial 
(marketed) tablet formulation administered with a low-fat/low-calorie meal relative to 
administration under fasting conditions.
To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial 
(marketed) tablet formulation administered with a high-fat/high calorie meal relative to 
administration under fasting conditions.
5.2.2
Study Secondary Objective
To evaluate the safety and tolerability of a single oral dose of 400 mg maribavir commercial 
(marketed) tablet formulation when administered under fasting conditions, with a low-fat/low-
calorie meal and with a high-fat/high-calorie meal.
5.2.3
Study Exploratory Objective
To evaluate other PK parameters of a single oral dose of 400 mg maribavir commercial 
(marketed) tablet formulation when administered under fasting conditions, with a 
low-fat/low-calorie meal and with a high-fat/high-calorie meal.
5.3
Endpoints
5.3.1
Primary Endpoints
The following PK parameters in plasma will be analyzed for maribavir:

Maximum observed concentration (Cmax)

Area under the concentration-time curve from time 0 to the time of the last 
quantifiable concentration (AUClast)

Area under the concentration-time curve from time 0 to infinity, calculated using the 
observed value of the last quantifiable concentration (AUC∞)
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5.3.2
Secondary Endpoints

TEAEs and their number, severity, seriousness, and causality 

Changes in vital signs, ECGs, and clinical laboratory results (hematology, chemistry, 
and urinalysis) from baseline to post-baseline time points, and evaluation of clinical 
signs.
5.3.3
Exploratory Endpoints
Exploratory PK endpoints include (if applicable, but are not limited to) additional PK parameters 
for maribavir as follows:

Concentration at 12 hours postdose (C12)

Area under the concentration-time curve from time 0 to 12 (AUC12)

Time to first occurrence of Cmax (tmax)

Area under the curve from the last quantifiable concentration to infinity, calculated 
using the observed value of the last quantifiable concentration, expressed as a 
percentage of AUC∞ (AUCextrap%)

Terminal disposition phase rate constant (λz)

Terminal disposition phase half-life (t½z)

Apparent volume of distribution during the terminal disposition phase after oral 
administration, calculated using the observed value of the last quantifiable 
concentration (Vz/F)

Apparent clearance after oral administration, calculated using the observed value of 
the last quantifiable concentration (CL/F)

Lag time to first quantifiable concentration in plasma (tlag)
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6.0
STUDY DESIGN AND DESCRIPTION
6.1
Study Design
This is a single-center, open-label, single-dose, randomized, 3-period, 6-sequence, crossover 
study in healthy adult participants.
Study schematic and dose regimens are shown in Table 2.a and Table 2.b. The schedule of 
assessments is shown in Schedule of Study Procedures (Section 3.0).
A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be 
administered orally under 3 different feeding conditions:
1) Fasting (Treatment A),
2) Fed following a low-fat/low-calorie meal (Treatment B), and 
3) Fed following a high-fat/high-calorie meal (Treatment C).
There will be a washout period of a minimum of 72 hours between each ID dosing.
PK samples will be collected predose and up to 36 hours postdose in each treatment period.
Safety and tolerability will be assessed throughout the study by TEAEs, vital signs, ECGs, and 
clinical laboratory evaluations.
The CRU will contact all participants (including participants who terminate the study early) 
7 (±4) days after the last ID administration by telephone or other methods per CRU standards to 
determine if any AE has occurred or concomitant medications have been taken since the last 
study visit. If clinically significant findings are observed upon discharge, participants may return 
to the CRU for re-evaluation per Investigator’s discretion.
6.2
Dose Escalation
Not applicable.
6.3
Stopping Rules
Not applicable.
6.4
Rationale for Study Design, Dose, and Endpoints
6.4.1
Rationale of Study Design
This study is being conducted to assess the effect of a low-fat/low-calorie and a 
high-fat/high-calorie meal on the PK profile of maribavir after a single oral dose.
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Participants will be randomized to treatment sequences to minimize assignment bias. A 
crossover design is used to reduce the residual variability as every participant acts as their own 
control.
The washout period of 72 hours between doses is considered sufficient to prevent carryover 
effects of the preceding treatment.
6.4.2
Rationale for Dose
The 400 mg single oral dose of maribavir was selected as this is the recommended therapeutic 
single dose according to the LIVTENCITY (maribavir) US prescribing information [8]. Based 
on results from Study CMAB1002, food is expected to reduce maribavir exposure by 
approximately 27%. The current dose level is thus expected to provide a robust PK profile under 
the different dosing food conditions in this study.
6.4.3
Rationale for Endpoints
6.4.3.1
Pharmacokinetic Endpoints
The PK endpoints are standard for this type of study.
6.4.3.2
Safety Endpoints
The key safety endpoints are typical for Phase 1 studies and will be assessed through monitoring 
of TEAEs, vital signs, ECGs, laboratory assessments, and physical examinations.
6.4.4
Critical Procedures Based on Study Objectives: Timing of Procedures 
For this study, the critical component is the blood collection for plasma concentrations of 
maribavir, and is to be collected as close to the scheduled times defined in this protocol as 
possible.
6.5
Study Design/Dosing/Procedures Modifications Permitted Within Protocol 
Parameters
The dose and administration of the ID to any participant may not be modified. If necessary, a 
participant may be discontinued for the reasons described in Section 7.5 and Section 7.6.
6.6
Study Beginning and End/Completion
6.6.1
Definition of Beginning of the Study
The beginning of the study will be defined as the beginning of the screening (ie, signing of the 
Informed Consent Form [ICF]) by the first participant.
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6.6.2
Definition of End of the Study
The end of study is defined as the date of the last scheduled procedure ie, follow-up contact, as 
outlined in the Schedule of Study Procedures (Section 3.0).
A study participant is considered to have completed the study if the participant has completed the 
last scheduled procedure ie, the follow-up contact, as outlined in the Schedule of Study 
Procedures (Section 3.0).
6.6.3
Definition of Study Completion
The end of the study is scheduled after completion of the evaluations in the follow-up contact for 
the last participant in the study.
This time period may change in the event that the study is terminated early or the last participant 
is lost to follow-up. 
6.6.4
Definition of Study Discontinuation
Celerion reserves the right to terminate the study in the interest of participant welfare.
The Sponsor reserves the right to suspend or terminate the study at any time.
6.6.5
Criteria for Premature Termination or Suspension of the Study
The study will be completed as planned unless one or more of the following criteria are satisfied 
that require temporary suspension or early termination of the study:

New safety information of the ID that indicates a change in the known product risk-benefit 
profile, such that the risk is no longer acceptable for participants participating in the study.

Significant violation of Good Clinical Practice (GCP) that compromises the ability to achieve 
the primary study objectives or compromises participant safety.
6.6.6
Criteria for Premature Termination or Suspension of a Site
Not applicable.
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7.0
SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS
7.1
Inclusion Criteria 
Participants must fulfill the following inclusion criteria before the first dose of the ID to be 
eligible for participation in the study:
1. An understanding, ability, and willingness to fully comply with study procedures and 
restrictions. 
2. Ability to voluntarily provide written, signed, and dated (personally or via a legally 
authorized representative) informed consent to participate in the study.
3. Age 19-55 years, inclusive at the time of consent, at the screening visit. The date of signature 
of the informed consent is defined as the beginning of the screening period. 
4. Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable 
contraceptive requirements of the protocol or female of non-childbearing potential. 
Additional details are outlined in Appendix D.
5. Healthy as determined by the Investigator or designee on the basis of screening evaluations 
and medical history. Healthy status is defined by absence of evidence of any active or 
chronic disease following a detailed medical and surgical history, a complete physical 
examination including vital signs, 12-lead ECG, hematology, blood chemistry (includes TSH 
and FT4 at the screening visit), and urinalysis.
6. Hemoglobin for males 135.0 g/L and females 120.0 g/L, at the screening visit and on 
Day -1 of Treatment Period 1.
7. BMI between 18.0 and 30.0 kg/m2, inclusive with a body weight >50 kg (110 lbs), at the 
screening visit.
8. Ability to swallow a dose of the ID.
7.2
Exclusion Criteria
Participants must not be enrolled in the study if they meet any of the following criteria before the 
first dose of the ID:
1. History or presence of gastritis, GI tract, hepatic disorder or cholecystectomy, history of 
treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in 
the opinion of the Investigator or designee, may affect the absorption, distribution, 
metabolism, or elimination of the ID.
2. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or 
psychiatric disease, gall bladder removal, or current recurrent disease that could affect the 
action, absorption, or disposition of the ID, or clinical or laboratory assessments.
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3. Current or relevant history of physical or psychiatric illness, any medical disorder that may 
require treatment or make the participant unlikely to fully complete the study, or any 
condition that presents undue risk from the ID or procedures.
4. Known or suspected intolerance or hypersensitivity to the ID, closely related compounds, or 
any of the stated ingredients and excipients.
5. Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose 
of the ID.
6. Has diarrhea within 4 hours of the first dose of the ID.
7. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to 
receiving the first dose of the ID.
8. Within 30 days prior to the first dose of the ID:
Have used any investigational product (if elimination half-life is <6 days, otherwise 
5 half-lives).
Have been enrolled in a clinical study (including vaccine studies) that, in the Investigator 
or designee’s opinion, may impact this Takeda-sponsored study.
Have had any substantial changes in eating habits, as assessed by the Investigator or 
designee.
9. Systolic blood pressure >140 mmHg or <90 mmHg, and diastolic blood pressure 
>90 mmHg or <50 mmHg, at the screening visit.
10. Twelve-lead ECG demonstrating QTc >450 msec at the screening visit. If QTc exceeds 
450 msec, the ECG should be repeated 2 more times and the average of the 3 QTc values 
should be used to determine the participant’s eligibility.
11. Known history of alcohol or other substance abuse within the last year.
12. Male participants who consume more than 21 units of alcohol per week or 3 units per day. 
Female participants who consume more than 14 units of alcohol per week or 2 units per day 
(1 alcohol unit=1 beer or 1 wine [5 oz/150 mL] or 1 liquor [1.5 oz/40 mL] or 0.75 oz 
alcohol).
13. A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of 
Treatment Period 1. Urine samples are to be tested for amphetamines, barbiturates, 
benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine.
14. A positive HIV, HBsAg, or HCV antibody screen at the screening visit.
15. Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products 
in any form (eg, gum, patch). Ex-users must self-report that they have stopped using tobacco 
for at least 3 months prior to receiving the first dose of the ID.
16. Routine consumption of more than 2 units of caffeine per day or participants who experience 
caffeine withdrawal headaches. (1 caffeine unit is contained in the following items: one 6 oz 
[180 mL] cup of coffee, two 12 oz [360 mL] cans of cola, one 12 oz cup of tea, three 1 oz 
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[85 g] chocolate bars). Decaffeinated coffee, tea, or cola are not considered to contain 
caffeine.
17. Current use of any prescription medication with the exception of hormonal contraceptives
and hormonal replacement therapy. Current use is defined as use within 30 days of the first 
dose of the ID. Current use of any over-the-counter medication (including over-the-counter 
multi-vitamin, herbal, or homeopathic preparations) within 14 days of the first dose of the 
ID. Hormonal contraceptives (refer to Appendix D) and hormonal replacement therapy may 
be permitted if the participant has been on the same stable dose for at least 3 months prior to 
first dose of the ID. Appropriate sources (eg, Flockhart TableTM) will be consulted to confirm 
lack of PK/pharmacodynamic interaction with the ID. 
18. Current use of antacids, proton pump inhibitors, or H2 antagonists within 14 days of the first 
dose of the ID.
19. Inability or unwillingness to consume 100 percent of high-fat meal or low-fat meal 
(including participants with lactose or gluten intolerance).
20. Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal 
reflux, asthma treatment with albuterol, or zinc supplementation.
21. Participants with dry mouth syndrome or burning mouth syndrome or participants suffering 
from dysgeusia.
7.3
Excluded Medications, Supplements, Dietary Products
Concomitant medications will be prohibited as listed in the exclusion criteria in Section 7.2. 
After the first dose of the ID, acetaminophen (up to 2 g per 24 hour period) may be administered 
at the discretion of the Investigator or designee. Hormonal contraceptives (refer to Appendix D) 
and hormonal replacement medication may be permitted if the female participant has been on the 
same stable dose for at least 3 months prior to the first dose of the ID.
If deviations occur, the Investigator or designee in consultation with the Sponsor if needed will 
decide on a case by case basis whether the participant may continue participation in the study.
All medications taken by participants during the course of the study will be recorded.
Use of excluded agents (prescription or non-prescription) or dietary products is outlined in
Table 7.a.
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Table 7.a
Excluded Medications, Supplements, and Dietary Products
Category
Prohibited Between Screening and the First 
Dosing of the ID (Days -28 to predose 
[Day 1])
Prohibited After the First 
Dosing of the ID (Day 1) to 
Follow-Up 
Alcohol
From 48 hours prior to the first dosing of ID.
From the first dosing of ID until 
the end of PK collection in 
Treatment Period 3.
Xanthine and/or caffeine
From 72 hours prior to the first dosing of ID.
Medications 
See Section 7.1 and Section 7.2.
See Section 7.1 and Section 7.2
Nicotine- and tobacco-
containing products
From 3 months prior to the first dosing of ID.
From the first dosing of ID until 
the end of PK collection in 
Treatment Period 3.
Food
Grapefruit/Seville orange
From 14 days prior to the first dosing of ID.
From the first dosing of ID until 
the end of PK collection in 
Treatment Period 3.
Pine nuts
From 7 days prior to the first dosing of ID.
7.4
Diet, Fluid, Activity 
7.4.1
Diet and Fluid
Water (except water provided with each dosing) will be restricted between 1 hour prior to and 
1 hour after each dosing of the ID, but will be allowed ad libitum at all other times. Other fluids 
may be given as part of meals and snacks but will be restricted at all other times throughout the 
confinement period.
In Treatment A, participants will fast overnight for at least 10 hours prior to dosing of the ID. 
Participants will continue the fast for at least 4 hours postdose.
In Treatment B, participants will fast overnight for at least 10 hours until 30 minutes prior to 
their scheduled morning dose of the ID, when they will be given a low-fat/low-calorie meal, as 
presented in Table 7.b which will be entirely consumed within 30 minutes. Participants will fast 
for at least 4 hours postdose. 
In Treatment C, participants will fast overnight for at least 10 hours until 30 minutes prior to 
their scheduled morning dose of the ID, when they will be given a high-fat/high-calorie meal, as 
presented in Table 7.b which will be entirely consumed within 30 minutes. Participants will fast 
for at least 4 hours postdose.
When confined, standard meals and snacks will be provided at appropriate times, except when 
they are required to fast. When confined in the CRU, participants will be required to fast from all 
food and drink (including gum, mints, etc). Only water will be allowed between meals and 
snacks.
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Each meal and/or snacks served at the CRU will be standardized and will be similar in caloric 
content and composition (except for the meal served as part of Treatment B and Treatment C) 
and will be taken at approximately the same time in each treatment period.
Table 7.b
Examples of Low-Fat/Low-Calorie and High-Fat/High-Calorie Meals and 
Breakdown of Calories and Contents
Low-Fat/Low-Calorie Meal 
(Treatment B)
High-Fat/High-Calorie Meal 
(Treatment C)
Total calories (kCal)
400-500
800-1000
Protein calories (kCal) (% 
of total calories; weight)
110 (27%; 27 grams)
150 (19%; 38 grams) 
Carbohydrate calories 
(kCal) (% of total calories; 
weight)
190 (47%; 47 grams)
250 (31%; 63 grams)
Fat calories (kCal) (% of 
total calories; weight)
100-125 (25%; 11-14 grams)
500-600 (50%; 55-65 grams)
Saturated and unsaturated 
fat (grams)
4 g; 6 g
Example of breakfast

Eight ounces milk (1% fat)

One boiled egg

One packet flavored instant 
oatmeal made with water
(This low-fat breakfast contains 
approximately 387 kCal and has 
10 grams of fat)

Eight ounces of whole milk

Two eggs fried in butter

Two strips of bacon

Two slices of toast with butter

Four ounces of hash brown potatoes
(This meal’s fat content accounts for 
approximately 50% of total kCal)
7.4.2
Activity
Participants will remain ambulatory or seated upright for the first 4 hours postdose, except when 
they are supine or semi reclined for study procedures. 
However, should AEs occur at any time, participants may be placed in an appropriate position or 
will be permitted to lie down on their right side.
Participants will be instructed to refrain from strenuous physical activity which could cause 
muscle aches or injury, including contact sports at any time from screening until completion of 
the study.
7.5
Criteria for Discontinuation or Withdrawal of a Participant
The primary reason for discontinuation or withdrawal of the participant from the study or ID 
should be recorded in the case report form (CRF) using the following categories
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1. AE: The participant has experienced an AE that requires early termination because continued 
participation imposes an unacceptable risk to the participant’s health or the participant is 
unwilling to continue because of the AE.
Liver Function Test (LFT) Abnormalities:
ID should be discontinued immediately with appropriate clinical follow-up (including 
repeat laboratory tests, until a participant’s laboratory profile has returned to 
normal/baseline status, see Section 9.2.8), if the following circumstances occur at any 
time during ID treatment:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >8 × upper 
limit of normal (ULN), or 

ALT or AST >5 × ULN and persists for more than 2 weeks, or 

ALT or AST >3 × ULN in conjunction with elevated total bilirubin >2 × ULN or 
international normalized ratio >1.5, or 

ALT or AST >3 × ULN with appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%).
QTcF interval:
ID should be discontinued immediately with appropriate clinical follow-up if a QTcF 
interval >500 msec or if there is an increase of QTcF >60 msec above baseline detected 
by ECG and confirmed with a repeat ECG. Appropriate clinical follow-up includes a 
repeat ECG.
2. Significant protocol deviation: The discovery post-enrollment that the participant failed to 
meet protocol entry criteria or did not adhere to protocol requirements, and continued 
participation poses an unacceptable risk to the participant’s health.
3. Lost to follow-up: Attempts to contact the participants were unsuccessful. Attempts to 
contact the participant must be documented in the participant’s source documents.
4. Voluntary withdrawal: The participant (or participant’s legally acceptable representative) 
wishes to withdraw from the study. The reason for withdrawal, if provided, should be 
recorded in the CRF.
Note: All attempts should be made to determine the underlying reason for the withdrawal 
and, where possible, the primary underlying reason should be recorded (ie, withdrawal due to 
an AE should not be recorded in the “voluntary withdrawal” category). If a participant 
chooses to withdraw from study participation due to personal concerns related to the 
COVID-19 pandemic (other than a COVID-19-related AE), this should be specified as the 
reason for participant withdrawal in the CRF.
5. Study termination: The Sponsor, IRB/IEC, or regulatory agency terminates the study.
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6. Pregnancy: as described in Appendix D.
7. Participants may be withdrawn from the study by the Investigator or designee for the 
following reasons:

Difficulties in blood collection.

Positive urine drug or alcohol test.
8. Other. The specific reasons for discontinuation should be entered into the CRF including 
unavoidable circumstances such as the COVID-19 pandemic. Participants may be withdrawn 
from the study at any time at the discretion of the Investigator or Sponsor for safety reasons 
which should be entered into the CRFs.
7.6
Procedures for Discontinuation or Withdrawal of a Participant
The Investigator may discontinue a participant’s study participation at any time during the study 
when the participant meets the study termination criteria described in Section 7.5. In addition, a 
participant may discontinue his or her participation without giving a reason at any time during 
the study. Should a participant’s participation be discontinued, the primary criterion for 
termination must be recorded by the Investigator. In addition, efforts should be made to perform 
all procedures scheduled for the end-of-study or early termination as described in Section 3.0.
7.7
Participant Replacement
Replacement of discontinued or withdrawn participants due to any reason will be assessed on a 
case by case basis by the Sponsor and Investigator to ensure a minimum of 24 PK-evaluable 
participants complete the study.
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8.0
CLINICAL STUDY MATERIAL MANAGEMENT
8.1
Clinical Investigational Drug
Product Name:
Maribavir (TAK-620)
Strength:
200-mg
Dose:
400 mg
Dosage Form/Formulation:
Tablet (commercial [marketed] form)
Dosing Regimen:
Single dose
Route of Administration:
Oral
8.1.1
Clinical Investigational Drug Labeling
ID containers will be affixed with a clinical label in accordance with local regulatory 
requirements.
8.1.2
Clinical Investigational Drug Inventory and Storage
The same lot number will be used throughout the study. The lot numbers and expiration dates 
(where available) of the IDs supplied will be recorded in the final report. IDs will be stored 
according to the product labels provided with the product.
Records will be made of the receipt, preparation, dispensing, and final disposition of the IDs 
supplied.
8.1.3
Clinical Investigational Drug Blinding
This is an open-label study.
8.1.4
Randomization Code Creation and Storage
A computerized randomization scheme will be created by a Celerion statistician.
Treatments A, B, and C will be randomized to 1 of 6 sequences as indicated in (Table 8.a).
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Table 8.a
Randomization Sequence
Sequences
Number of participants (N)
Treatment 
Period 1
Treatment 
Period 2
Treatment 
Period 3
1
5
A
B
C
2
5
B
C
A
3
5
C
A
B
4
5
C
B
A
5
5
A
C
B
6
5
B
A
C
Treatment A = maribavir tablet (2 x 200 mg), fasting
Treatment B = maribavir tablet (2 x 200 mg), fed - following a low-fat/low-calorie meal
Treatment C = maribavir tablet (2 x 200 mg), fed - following a high-fat/high-calorie meal.
8.1.5
Clinical Study Blind Maintenance/Unblinding Procedure
Not applicable.
8.1.6
Accountability and Destruction of Sponsor-Supplied Drugs
Records will be made of the receipt and dispensing of the IDs supplied. At the conclusion of the 
study, any unused ID will be retained by Celerion, returned to the Sponsor or designee, or 
destroyed, as per Sponsor instructions. If no supplies remain, this fact will be documented in the 
pharmacy product accountability records.
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9.0
STUDY PROCEDURES
9.1
Administrative Procedures
9.1.1
Informed Consent Procedure
The purpose of the study, the procedures to be carried out and the potential hazards will be 
described to the participants in non-technical terms. Participants will be required to read, sign, 
and date an ICF, and will be assured that they may withdraw from the study at any time without 
jeopardizing their medical care.
Participants will be given a copy of their signed ICF.
9.1.1.1
Assignment of Screening and Randomization Numbers 
Each participant will be assigned a unique identification number upon screening. Participants 
who complete the study screening assessments and meet all the eligibility criteria will be 
assigned a unique randomization identification number at the time of the first dose of the ID, 
different from the screening number and will receive the corresponding product, according to a 
randomization sequence.
If replacement participants are used, the replacement participant number will be 100 more than 
the original (eg, Participant No. 101 will replace Participant No. 1).
9.1.1.2
Investigational Drug Assignment
All participants will receive the treatments as detailed in Section 8.1.
9.1.2
Inclusion and Exclusion 
Please refer to Section 7.1 and Section 7.2.
9.1.3
Medical History/Demography
Medical history and demographic data, including name, sex, age, race, ethnicity, and history of 
tobacco use will be recorded.
9.1.4
Concomitant Medications
Concomitant medications will be prohibited as listed in Section 7.3. All medications taken by 
participants during the course of the study will be recorded.
9.2
Clinical Procedures and Assessments
The Schedule of Study Procedures (Section 3.0) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the Investigator or designee and/or the Sponsor 
for reasons related to participant safety.
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For this study, collection of blood for maribavir PK is the critical parameter and needs to be 
collected as close to the exact time point as possible. All other procedures should be completed 
as close to the prescribed/scheduled time as possible, but can be performed prior to or after the 
prescribed/scheduled time.  
Any nonscheduled procedures required for urgent evaluation of safety concerns take precedence 
over all routine scheduled procedures.
9.2.1
Full Physical Examination
A full physical examination will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). Additional physical examinations may be performed at other times, if deemed 
necessary by the Investigator or designee.
9.2.2
Height and Weight
Body height (cm) and weight (kg) will be reported as outlined in the Schedule of Study 
Procedures (Section 3.0).
9.2.3
BMI
BMI will be calculated based on the height and weight measured at the screening visit.
9.2.4
Vital Signs
Single measurements of temperature, respiration rate, blood pressure, and pulse rate, will be 
measured as outlined in the Schedule of Study Procedures (Section 3.0). Additional vital signs 
may be taken at any other times, if deemed necessary.
Blood pressure and pulse rate measurements will be performed with participants in a supine 
position, except when they are semi-reclined because of study procedures and/or AEs 
(e.g. nausea, dizziness) or if deemed necessary by the Investigator or designee. Participants
should be in the appropriate position for at least 5 minutes prior to obtaining vital signs.
Blood pressure and pulse rate will be measured within 2 hours prior to Day 1 dosing in each 
treatment period for the predose time point. When scheduled postdose, vital signs will be 
performed within approximately 15 minutes of the scheduled time point. 
9.2.5
12-Lead ECG
Single 12-lead ECGs will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). Additional ECGs may be taken at any other times, if deemed necessary by the 
Investigator or designee.
At screening, if QTc exceeds 450 msec, the ECG should be repeated 2 more times and the 
average of the 3 QTc values should be used to determine the participant’s eligibility.
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ECGs will be performed with participants in a supine position. All ECG tracings will be 
reviewed by the Investigator or designee. The participant must be resting in the supine position 
for at least 5 minutes prior to collecting the ECG.
ECGs will be measured within 2 hours prior Day 1 dosing in each treatment period for the 
predose time point. When scheduled postdose, ECGs will be performed within approximately 
20 minutes of the scheduled time point.
9.2.6
Investigational Drug Administration
The ID will be provided as described in Section 8.1.
Treatments are described in Table 2.b.
The ID will be administered orally with approximately 240 mL of water.
The pharmacy at the CRU will provide each dose in individual unit dose containers for each 
participant, as appropriate.
Participants will be instructed not to crush, split, or chew the tablets.
Dosing should occur at approximately the same time in each treatment period. For Treatment B 
and Treatment C, a meal will be provided 30 minutes prior to the ID dosing.
The exact clock time of the ID dosing will be recorded.
A qualified designee will be responsible for monitoring the administration of the assigned doses. 
A mouth check will be performed by the qualified designee to ensure that the participants have 
swallowed the ID. Once a participant has finished the dosing water, the qualified designee will 
use a flashlight and a tongue depressor to check the participant’s mouth. Participant’s hands will 
also be verified to ensure that the ID was ingested.
9.2.7
AE Monitoring
Participants will be monitored throughout the study for TEAEs and/or procedures as described in 
Section 10.0.
9.2.8
Laboratory Procedures and Assessments
All tests listed below will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). In addition, laboratory safety tests may be performed at various unscheduled time 
points, if deemed necessary by the Investigator or designee.
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9.2.8.1
Clinical Laboratory Tests
Hematology
Hematology will consist of the following tests:
Hemoglobin
Red blood cell count
Hematocrit 
Platelet count
Total and differential leukocyte count
Chemistry 
Serum chemistry tests will be performed after at least an 8-hour fast; however, in case of 
dropouts or rechecks, participants may not have fasted for 8 hours prior to when the serum 
chemistry sample being taken.
Chemistry evaluations will consist of the following standard chemistry panel:
Blood Urea Nitrogen
Albumin
Bilirubin (total and direct)
Sodium
Alkaline phosphatase
Potassium
AST
Chloride
ALT
Glucose (fasting)
FT4 **
Creatinine *
TSH **
* At screening, creatinine clearance will be calculated using the Cockcroft-Gault formula.
** At screening only
Urinalysis
Urinalysis will consist of the following tests:
pH
Bilirubin
Specific gravity
Blood *
Protein *
Nitrite *
Glucose
Urobilinogen
Ketones
Leukocyte esterase *
* If urinalysis is positive for protein, blood, nitrite and/or leukocyte esterase, a microscopic examination (for red 
blood cells, white blood cells, bacteria, casts, and epithelial cells) will be performed.
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Other 
HIV test
Urine drug screen
-
Opiates (includes morphine, heroin 
(diacetylmorphine), codeine, 6-acetylmorphine, 
dihydrocodeine, hydrocodone, thebaine, and, 
hydromorphone)
-
Amphetamines
-
Barbiturates
-
Benzodiazepines
-
Cocaine
-
Cannabinoids
-
Methadone
-
Phencyclidine
HBsAg
HCV
Urine alcohol screen
Serum pregnancy test (for females only)
Follicle stimulating hormone (FSH; for 
postmenopausal females only)
COVID-19 (Severe acute respiratory syndrome-
Coronavirus-1 [SARS-CoV-2] polymerase chain 
reaction test or equivalent)
9.3
PK Samples
Samples for maribavir PK assessment will be collected as outlined in the Schedule of Study 
Procedures (Section 3.0).
Instructions for PK sample collection, processing, and shipping will be provided in separate 
documents. 
Primary specimen collection parameters are provided in Table 9.a and allowed windows are 
provided in Table 9.b.
Table 9.a
Primary Specimen Collections
Specimen Name
Primary 
Specimen
Primary Specimen 
Derivative
Description of 
Intended Use
Sample 
Collection
Plasma sample for PK
Blood
Plasma
Plasma sample for PK 
analysis
Mandatory
Table 9.b
Sampling Collection Window
Sample Collection Time
Sampling Window
Predose
< -1 hour
>0 - ≤4 hours postdose
± 5 minutes
>4 - ≤36 hours postdose
± 15 minutes
9.3.1
PK Measurements 
Samples from all participants will be assayed even if the participants do not complete the study. 
Samples for determination of maribavir in plasma will be analyzed using validated bioanalytical 
methods.
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Pharmacokinetic parameters of maribavir will be calculated from the individual 
concentration-time profiles from all evaluable participants using NCA methods. Actual sampling 
times, rather than scheduled sampling times, will be used in all computations involving sampling 
times. 
9.3.1.1
Plasma for PK Measurements
The following PK parameters will be calculated from plasma concentrations of maribavir, unless 
otherwise specified:
AUClast:
Area under the concentration-time curve from time 0 to the time of the 
last quantifiable concentration.
AUC:
Area under the concentration-time curve from time 0 to infinity, 
calculated using the observed value of the last quantifiable concentration.
AUC12:
Area under the concentration-time curve from time 0 to 12
AUCextrap%:
Area under the curve from the last quantifiable concentration to infinity, 
calculated using the observed value of the last quantifiable concentration, 
expressed as a percentage of AUC.
CL/F:
Apparent clearance after oral administration, calculated using the 
observed value of the last quantifiable concentration.
Cmax:
Maximum observed concentration.
C12:
Concentration at 12 hours postdose.
tmax:
Time to first occurrence of Cmax.
tlag:
Lag time to first quantifiable concentration in plasma.
λz
Terminal disposition phase rate constant.
t½z:
Terminal disposition phase half-life.
Vz/F:
Apparent volume of distribution during the terminal disposition phase 
after oral administration, calculated using the observed value of the last 
quantifiable concentration.
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No value for AUC, AUCextrap%, CL/F, Vz/F, λz, or t½z will be reported for cases that do not 
exhibit a terminal log-linear phase in the concentration versus time profile.
No PK parameters will be calculated for participants with detectable concentrations at 4 or fewer 
consecutive time points. 
Individual and mean plasma concentration-curves (both linear and log-linear) will be included in 
the final report.
Additional PK parameters may be estimated as appropriate.
9.3.2
Biomarker Measurements 
Not applicable.
9.3.3
PGx Measurements 
Not applicable.
9.3.4
Confinement
Participants will be housed on Day -1 of Treatment Period 1, at the time indicated by the CRU, 
until after the 36-hour blood draw and/or study procedures of Treatment Period 3 as outlined in 
the Schedule of Study Procedures (Section 3.0). Participants may be admitted earlier for 
COVID-19 testing not related to study protocol as per CRU requirements.
At all times, a participant may be required to remain at the CRU for longer at the discretion of 
the Investigator or designee.
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10.0
ADVERSE EVENTS
10.1
Definitions and Elements of AEs
An AE is defined as any untoward medical occurrence in a clinical investigation participant who 
has signed informed consent to participate in a study; it does not necessarily have to have a 
causal relationship with the treatment.
An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, 
whether or not it is considered related to the drug.
An untoward finding generally may:

Indicate a new diagnosis or unexpected worsening of a preexisting condition. 
(Intermittent events for pre-existing conditions or underlying disease should not be 
considered AEs.)

Necessitate therapeutic intervention.

Require an invasive diagnostic procedure.

Require discontinuation or a change in dose of the ID or a concomitant medication.

Be considered unfavorable by the Investigator for any reason.
Diagnoses versus signs and symptoms:

Each event should be recorded to represent a single diagnosis. Accompanying signs 
(including abnormal laboratory values or ECG findings) or symptoms should NOT 
be recorded as additional AEs. If a diagnosis is unknown, sign(s) or symptom(s) 
should be recorded appropriately as an AE(s).
Laboratory values and ECG findings:

Changes in laboratory values or ECG parameters maybe considered AEs if they are 
judged to be clinically significant (ie, if some action or intervention is required or if 
the Investigator judges the change to be beyond the range of normal physiologic 
fluctuation). A laboratory re-test and/or continued monitoring of an abnormal value 
are not considered an intervention. In addition, repeated or additional noninvasive 
testing for verification, evaluation or monitoring of an abnormality is not considered 
an intervention.

If abnormal laboratory values or ECG findings are the result of pathology for which 
there is an overall diagnosis (eg, increased creatinine in renal failure), the diagnosis 
only should be reported appropriately as an AE.
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Pre-existing conditions:

A pre-existing condition (present at the time of signing of informed consent) is 
considered a concurrent medical history condition and should NOT be recorded as 
an AE. A baseline evaluation (eg, laboratory test, ECG, X-ray, etc) should NOT be 
recorded as an AE unless related to a study procedure. However, if the participant
experiences a worsening or complication of such a concurrent medical history 
condition, the worsening or complication should be recorded appropriately as an AE 
(worsening or complication occurs after informed consent is signed). Investigators 
should ensure that the event term recorded captures the change in the condition (eg, 
“worsening of…”).

If a participant has a pre-existing episodic condition (eg, asthma, epilepsy), any 
occurrence of an episode should only be captured as an AE if the episodes become 
more frequent, serious, or severe in nature, that is, Investigators should ensure that 
the AE term recorded captures the change from Baseline in the condition (eg 
“worsening of…”).

If a participant has a degenerative concurrent condition (eg, cataracts, rheumatoid 
arthritis), worsening of the condition should only be captured as an AE if occurring 
to a greater extent to that which would be expected. Again, Investigators should 
ensure that the AE term recorded captures the change in the condition (eg, 
“worsening of…”).
Worsening of AEs:

If the participant experiences a worsening or complication of an AE after the first 
administration of the ID or after any change in ID, the worsening or complication 
should be recorded as a new AE. Investigators should ensure that the AE term 
recorded captures the change in the condition (eg, “worsening of…”).
Changes in severity of AEs:

If the participant experiences a change in the severity of an AE that is not associated 
with a change in ID, the event should be captured once with the maximum severity 
recorded.
Preplanned surgeries or procedures:

Preplanned procedures (surgeries or therapies) that were scheduled prior to signing 
of informed consent are not considered AEs. However, if a preplanned procedure is 
performed early (eg, as an emergency) due to a worsening of the pre-existing 
condition, the worsening of the condition should be captured appropriately as an AE. 
Complications resulting from any planned surgery should be reported as AEs.
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Elective surgeries or procedures:

Elective procedures performed where there is no change in the participant’s medical 
condition should not be recorded as AEs but should be documented in the 
participant’s source documents. Complications resulting from an elective surgery 
should be reported as AEs.
Overdose:

An overdose is defined as a known deliberate or accidental administration of 
investigational drug, to or by a study participant, at a dose above that which is 
assigned to that individual participant according to the study protocol. It is up to the 
Investigator or the reporting physician to decide whether a dose is to be considered 
an overdose, in consultation with the Sponsor.

All cases of overdose (with or without associated AEs) will be documented on an 
Overdose page of the (e)CRF, in order to capture this important safety information 
consistently in the database. AEs associated with an overdose will be documented on 
AE CRF(s) according to Section 10.0.

Serious adverse events (SAEs) of overdose should be reported according to the 
procedure outlined in Section 10.2.8.

In the event of drug overdose, the participant should be treated symptomatically.
10.1.1
SAEs
An SAE is defined as any untoward medical occurrence that at any dose:
1. Results in DEATH.
2. Is LIFE THREATENING.

The term “life threatening” 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.
3. Requires inpatient HOSPITALIZATION or prolongation of existing hospitalization.
4. Results in persistent or significant DISABILITY/INCAPACITY.
5. Is a CONGENITAL ANOMALY/BIRTH DEFECT.
6. Is an IMPORTANT MEDICAL EVENT that satisfies any of the following:

May require intervention to prevent items 1 through 5 above.

May expose the participant to danger, even though the event is not immediately life 
threatening or fatal or does not result in hospitalization.
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AEs that fulfill 1 or more of the serious criteria above are to be considered SAEs and should be 
reported and followed up in the same manner (see Section 10.1 and Section 10.1.1).
10.1.2
Adverse Events of Special Interest
Adverse events of special interest for maribavir include:

Dysgeusia

GI-related events
10.2
AE Procedures
10.2.1
Assigning Severity/Intensity of AEs
The different categories of severity/intensity are:
Mild:
An AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual 
activities of daily living.
Moderate:
An AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, 
causing discomfort but poses no significant or permanent risk of harm to the 
research participant.
Severe:
An AE that interrupts usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention.
10.2.2
Assigning Causality of AEs
The relationship of each AE to the ID will be assessed using the following categories:
Related:
An AE that follows a reasonable temporal sequence from administration of a 
drug (including the course after withdrawal of the drug), or for which a 
causal relationship is at least a reasonable possibility, ie, the relationship 
cannot be ruled out, although factors other than the drug, such as underlying 
diseases, complications, concomitant drugs and concurrent treatments, may 
also be responsible.
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Not Related:
An AE that does not follow a reasonable temporal sequence from 
administration of a drug and/or that can reasonably be explained by other 
factors, such as underlying diseases, complications, concomitant medications 
and concurrent treatments.
In addition, relationship (causality) to COVID-19 should be determined for all AEs. The 
relationship should be assessed as related if the Investigator considers that there is reasonable 
possibility that an event is due to COVID-19. Otherwise, the relationship should be assessed as 
not related.
Similarly, relationship (causality) to COVID-19 vaccines should be determined for all AEs. The 
relationship should be assessed as related if the Investigator considers that there is reasonable 
possibility that an event is due to COVID-19 vaccines. Otherwise, the relationship should be 
assessed as not related. If the AE has relationship to vaccination, specific verbatim term should 
be used, eg, post-vaccination fever, vaccination site burning.
In addition, if the causality assessment done by the Investigator determines that AEs are related 
or possible related to COVID-19 or the COVID-19 vaccine, the events should be assessed as not 
related to the ID. If the AE is related to COVID-19 vaccination, specific verbatim term(s) should 
be used, eg, post-vaccination fever, vaccination site burning.
10.2.3
Start Date
The start date of the AE is the date that the first signs/symptoms were noted by the participant 
and/or Investigator.
10.2.4
End Date 
The end date of the AE is the date at which the participant recovered, the event resolved but with 
sequelae or the participant died.
10.2.5
Pattern of Adverse Event (Frequency) 
Episodic AEs (eg, headache) or those which occur repeatedly over a period of consecutive days 
are intermittent. All other events are continuous.
10.2.6
Action Taken With Study Treatment

Drug withdrawn – the ID is stopped due to the particular AE.

Dose not changed – the particular AE did not require stopping the ID.

Unknown – only to be used if it has not been possible to determine what action has 
been taken.
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
Not applicable – the ID was stopped for a reason other than the particular AE eg, the 
study has been terminated, the participant died, dosing with the ID had not yet 
started or dosing with the ID was already stopped before the onset of the AE.
10.2.7
Outcome 

Recovered/resolved – participant returned to first assessment status with respect to 
the AE.

Recovering/resolving – the intensity is lowered by one or more stages: the diagnosis 
has or signs/symptoms have almost disappeared; the abnormal laboratory value 
improved, but has not returned to the normal range or to the baseline value; the 
participant died from a cause other than the particular AE with the condition 
remaining “recovering/resolving.”

Not recovered/not resolved – there is no change in the diagnosis, signs or symptoms; 
the intensity of the diagnosis, signs/symptoms or laboratory value on the last day of 
the observed study period has become worse than when it started; is an irreversible 
congenital anomaly; the participant died from another cause with the particular AE 
state remaining “Not recovered/not resolved.”

Recovered/resolved with sequelae – the participant recovered from an acute AE but 
was left with permanent/significant impairment (eg, recovered from a cardiovascular 
accident but with some persisting paresis).

Fatal – an AE that is considered as the cause of death.

Unknown – the course of the AE cannot be followed up due to hospital change or 
residence change at the end of the participant’s participation in the study.
10.2.8
Collection and Reporting of AEs, SAEs, Special Interest AEs, and Abnormal 
Liver Function Tests (LFTs)
10.2.8.1
Collection Period
Collection of AEs (ie, AEs, SAEs, Special Interest AEs, and Abnormal LFTs) will commence at 
the time the participant signs the informed consent. Routine collection of AEs will continue until 
the follow-up contact on Day 7 (±4 days), after the last dose of the ID. For participants who 
discontinue prior to the administration of the ID, AEs will be followed until the participant 
discontinues study participation. 
10.2.8.2
Reporting AEs
At each treatment period, the Investigator will assess whether any subjective AEs have occurred. 
A neutral question, such as “How have you been feeling?” may be asked. Participants may report 
AEs occurring at any other time during the study. Participants experiencing an SAE prior to the 
first exposure to the ID must be monitored until the symptoms subside and any clinically 
relevant changes in laboratory values have returned to Baseline or there is a satisfactory 
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explanation for the change. Nonserious AEs that begin prior to the first exposure to the ID, 
related or unrelated to the study procedure, need not be followed-up for the purposes of the 
protocol.
All participants experiencing AEs, whether considered associated with the use of the ID or not, 
must be monitored until the symptoms subside and any clinically relevant changes in laboratory 
values have returned to Baseline or until there is a satisfactory explanation for the changes 
observed. All AEs will be documented in the AE page of the CRF, whether or not the 
Investigator concludes that the event is related to the drug treatment. The following information 
will be documented for each event:

Event term.

Start and end date and time.

Pattern of AE (frequency).

Severity/Intensity.

Causality (Investigator’s opinion of the causal relationship between the event and 
administration of the ID).

Relationship to COVID-19.

Relationship to COVID-19 vaccine.

Action taken with ID.

Outcome of event.

Seriousness.
10.2.8.3
Reporting SAEs
When an SAE occurs through the AE collection period it should be reported according to the 
procedure outlined below:
A Takeda SAE form must be completed, in English and signed by the Investigator immediately 
or within 24 hours of first onset or notification of the event. The information should be 
completed as fully as possible but contain, at a minimum:

A short description of the event and the reason why the event is categorized as 
serious.

Participant identification number.

Investigator’s name.

Name of the ID.

Causality assessment.
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The SAE form should be transmitted within 24 hours to the attention of the contact listed in 
Section 14.1.1.
Any SAE spontaneously reported to the Investigator following the AE collection period should 
be reported to the Sponsor if considered related to study participation.
Reporting of SAEs that begin before first administration of the ID will follow the same 
procedure for SAEs occurring on treatment.
SAE Follow-Up
If information is not available at the time of the first report becomes available at a later date, the 
Investigator should complete a follow-up SAE form or provide other written documentation and 
fax it immediately within 24 hours of receipt. Copies of any relevant data from the hospital notes 
(eg, ECGs, laboratory tests, discharge summary, postmortem results) should be sent to the 
addressee, if requested.
All SAEs should be followed up until resolution or permanent outcome of the event. The 
timelines and procedure for follow-up reports are the same as those for the initial report.
10.2.8.4
Reporting Special Interest AEs 
Adverse events of Special Interest for maribavir include dysgeusia and GI-related events.
10.2.8.5
Reporting of Abnormal LFTs
If a participant is noted to have ALT or AST elevated >3 ×ULN on 2 consecutive occasions, the 
abnormality should be recorded as an AE. In addition, an LFT Increases CRF must be completed 
providing additional information on relevant recent history, risk factors, clinical signs and 
symptoms and results of any additional diagnostic tests performed.
If a participant is noted to have ALT or AST >3 ×ULN and total bilirubin >2 ×ULN for which an 
alternative etiology has not been identified, the event should be recorded as an SAE and reported 
as per Section 10.2.8.3. The Investigator must contact the Medical Monitor to discuss the 
relevant participant details and possible alternative etiologies, such as acute viral hepatitis A or B 
or other acute liver disease. Follow-up laboratory tests as described in Section 9.2.8 must also be 
performed. In addition, an LFT Increases CRF must be completed and transmitted with the 
Takeda SAE form (as per Section 10.2.9). 
10.2.9
Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities 
The Sponsor will be responsible for reporting all suspected unexpected serious adverse reactions 
(SUSARs) and any other applicable SAEs to regulatory authorities, Investigators and IRBs or 
IECs, as applicable, in accordance with national regulations in the countries where the study is 
conducted. Relative to the first awareness of the event by/or further provision to the Sponsor or 
Sponsor’s designee, SUSARs will be submitted within 7 days for fatal and life-threatening 
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events and 15 days for other serious events, unless otherwise required by national regulations. 
The Sponsor will also prepare an expedited report for other safety issues where these might 
materially alter the current benefit-risk assessment of an ID or that would be sufficient to 
consider changes in the ID products administration or in the overall conduct of the study. The 
investigational site also will forward a copy of all expedited reports to his or her IRB or IEC in 
accordance with national regulations.
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11.0
STATISTICAL METHODS
11.1
Statistical and Analytical Plans
Detailed methodology for data summary and statistical analyses of the data collected in this 
study will be documented in a statistical analysis plan (SAP). The SAP will be prepared by 
Celerion and agreed upon with the Sponsor. This document may modify the plans outlined in the 
protocol; however, any major modifications of the primary endpoints definition and/or its 
analysis will also be reflected in a protocol amendment. Additional statistical analyses other than 
those described in this section may be performed if deemed appropriate.
11.1.1
Analysis Sets
11.1.1.1
PK Set
All participants who received at least 1 dose of maribavir, did not vomit or had diarrhea within 
4 hours of the ID dosing, and have 5 or more postdose time points with evaluable postdose 
maribavir concentration values that enable NCA.
11.1.1.2
Safety Set
All participants who received at least 1 dose of maribavir will be included in the safety 
evaluations.
11.1.2
Analysis of Demography and Other Baseline Characteristics
Continuous demographic data (ie, age, weight, height, and BMI) will be listed and summarized 
using appropriate summary statistics. Categorical demographic data (ie, gender, race, and 
ethnicity) will also be listed and tabulated.
11.1.3
PK Analysis
Statistical analysis of PK data will be based on the PK set.
Individual maribavir plasma concentrations and PK parameters will be listed by participant and 
treatment, and summarized by treatment (maribavir plasma concentrations and PK parameters) 
and nominal time (maribavir plasma concentrations).
PK parameters (Cmax, AUClast, AUC∞, AUC12, AUCextrap%, C12, tmax, λz, t½z, CL/F, Vz/F, and tlag) 
will be computed using standard NCA. Actual time of sampling will be used to calculate the PK 
parameters. The PK endpoints will be presented descriptively. All individual concentration data 
and PK parameters will be listed with summary statistics such as geometric mean, median, 
arithmetic mean, SD, CV, minimum and maximum. Individual plasma concentration/time curves 
will be presented in linear/linear and log/linear scale. At least 3 PK time points within the 
terminal log-linear phase will be used to estimate the terminal rate constant for each participant 
in each treatment period.
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The appropriate PK analysis will be fully specified in the CPAP.
11.1.3.1
Food-effect estimation
A mixed-effect model will be applied to log-transformed Cmax, AUClast, and AUC∞with 
treatment, period, and sequence as fixed effects, and participant within sequence as a random 
effect. Point estimates and their associated 90% CIs will be constructed for the differences 
between Treatment B (low-fat/low-calorie meal) versus Treatment A (fasting), and Treatment C 
(high-fat/high-calorie meal) versus Treatment A (fasting). The point estimates and their 
associated 90% CIs will be then back transformed to provide point estimates and 90% CIs for the 
ratios of Treatment B (low-fat/low-calorie meal) versus Treatment A (fasting) and Treatment C 
(high-fat/high-calorie meal) versus Treatment A (fasting).
11.1.3.2
Non-Parametric Analysis
Analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed-Rank test. This 
analysis will be based on the PK data set.
11.1.3.3
Exploratory Analysis
In a separate analysis, both non-compartmental and compartmental PK modeling will be used to 
simulate and to project the steady-state AUC12, Cmax and C12 after theoretical regimens of 
multiple BID oral doses of 400 mg maribavir commercial (marketed) formulation under different 
dosing conditions (Treatment A, B, or C). The results from the exploratory analysis will not be 
listed in the CSR and will be detailed in a separate report.
Additional exploratory analyses may be conducted and reported separately.
11.1.4
Pharmacodynamic Analysis
Not applicable.
11.1.5
Safety Analysis
All safety data will be populated in the individual CRFs.
Dosing dates and times will be listed by participant.
Safety analysis will be based on safety data set.
TEAEs will be tabulated. Quantitative safety data as well as the difference to baseline, when 
appropriate, will be summarized using the appropriate descriptive statistics.
11.1.5.1
AEs
AEs will be coded using the most current version of Medical Dictionary for Regulatory 
Activities® (MedDRA®) available at Celerion and summarized by treatment for the number of 
participants reporting the TEAE and the number of TEAEs reported. Summaries in terms of 
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severity, seriousness, and relationship to the ID will also be provided. Treatment-emergent SAEs 
and AESIs will be summarized separately in a similar fashion. A by-participant AE data listing 
including verbatim term, coded term, treatment, severity, and relationship to treatment will be 
provided.
TEAEs are defined as those with a start date on or after the first dose of the ID, or with a start 
date before the date of first dose of the ID but increasing in severity after the first dose of the ID.
11.1.5.2
Clinical Laboratory Evaluation
Clinical laboratory results will be summarized by treatment and point of collection time and a 
shift table describing out of normal range shifts will be provided.
Individual results meeting potentially clinically significant (PCS) criteria for safety clinical 
laboratory assessments will be listed and summarized. The number and percentages of 
participants with at least one postdose result considered as a PCS will be provided. More detail 
will be provided in the SAP.
11.1.5.3
Vital Signs
Vital signs assessments will be summarized by treatment and point of time of collection.
Vital signs results meeting PCS criteria for vital signs assessments will be listed and 
summarized. The number and percentages of participants with at least one postdose result 
considered as a PCS will be provided. More detail will be provided in the SAP.
11.1.5.4
Other Safety Parameters 
ECGs will be summarized by treatment and point of time of collection. ECG results meeting 
PCS criteria for safety ECGs will be listed and summarized. The number and percentages of 
participants with at least one postdose result considered as a PCS will be provided. More detail 
will be provided in the SAP.
Medical history, including concurrent conditions, will be coded using the MedDRA® and 
concomitant medications will be coded using the World Health Organization (WHO) drug 
dictionary and will be listed by participant.
11.2
Interim Analysis and Criteria for Early Termination
Not applicable.
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11.3
Determination of Sample Size
A total of 24 participants should complete all treatment periods of the study.
Sample size calculations is performed using R package PowerTOST and were based on the 
following:

The intra-participant CV was assumed at 0.166 and 0.218, respectively for AUC∞and 
Cmax, which were estimated from the 90% CIs of the GMR of AUC∞, and Cmax in Study 
1263-104.

Reference data set is AUC∞or Cmax under fasting conditions; test data set is AUC∞or 
Cmax under fed conditions

Assumed GMR for Test / Reference: 0.80, 0.85, 0.90, 0.95, or 1.00

The estimated 90% CI of the GMR at 0.90, with N = 24, is within (0.80, 1.25) for both 
AUC∞and Cmax
Accounting for possible dropouts, a total of 30 participants will be enrolled.
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12.0
QUALITY CONTROL AND QUALITY ASSURANCE
12.1
Study-Site Monitoring Visits
Monitoring visits to the study site will be made periodically during the study to ensure that all 
aspects of the protocol are followed. Due to COVID-19, monitoring visits may also be conducted 
remotely. Source documents will be reviewed for verification of data recorded on the CRFs. 
Source documents are defined as original documents, data, and records. The Investigator and 
study site guarantee access to source documents by the Sponsor or its designee and by the IRB or 
IEC.
All aspects of the study and its documentation will be subject to review by the Sponsor or the 
Sponsor’s designee (as long as blinding is not jeopardized), including but not limited to the 
Investigator’s Binder, ID, participant medical records, informed consent documentation, and 
review of CRFs and associated source documents. It is important that the Investigator and other 
study personnel are available during the monitoring visits and that sufficient time is devoted to 
the process.
12.2
Protocol Deviations
The Investigator or study personnel should not deviate from the protocol, except where necessary 
to eliminate an immediate hazard to study participants. Should other unexpected circumstances 
arise that will require deviation from protocol-specified procedures, the Investigator should 
consult with the sponsor or designee (and IRB or IEC, as required) to determine the appropriate 
course of action. There will be no exemptions (a prospectively approved deviation) from the 
inclusion or exclusion criteria.
For COVID-19-related protocol deviations, the specific protocol deviation, the reason for the 
deviation, and the relationship to COVID-19 should be documented using CRU standard 
processes.
Significant deviations include, but are not limited to, those that involve fraud or misconduct, 
increase the health risk to the participant, or confound interpretation of primary study 
assessment. 
12.3
Quality Assurance Audits and Regulatory Agency Inspections
The study site also may be subject to quality assurance audits by the Sponsor or designees. In 
this circumstance, the Sponsor-designated auditor will contact the site in advance to arrange an 
auditing visit. The auditor may ask to visit the facilities where laboratory samples are collected, 
where the medication is stored and prepared, and any other facility used during the study. In 
addition, there is the possibility that this study may be inspected by regulatory agencies (such as 
FDA), including those of foreign governments (eg, the FDA, the United Kingdom Medicines and 
Healthcare Products Regulatory Agency - MHRA, the Pharmaceuticals and Medical Devices 
Agency of Japan - PMDA). If the study site is contacted for an inspection by a regulatory body, 
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the Sponsor should be notified immediately. The Investigator guarantees access for quality 
assurance auditors to all study documents as described in Section 12.1.
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13.0
ETHICAL ASPECTS OF THE STUDY
This study will be conducted with the highest respect for the individual participants 
(ie, participants) according to the protocol, the ethical principles that have their origin in the 
Declaration of Helsinki, and the International Conference on Harmonisation (ICH) Harmonised 
Tripartite Guideline for GCP. Each Investigator will conduct the study according to applicable 
local or regional regulatory requirements and align his or her conduct in accordance with the 
“Responsibilities of the Investigator” that are listed in Appendix A. The principles of Helsinki 
are addressed through the protocol and through appendices containing requirements for informed 
consent and Investigator responsibilities.
13.1
IRB and/or IEC Approval
IRBs and IECs must be constituted according to the applicable state and federal/local 
requirements of each participating region. The Sponsor or designee will require documentation 
noting all names and titles of members who make up the respective IRB or IEC. If any member 
of the IRB or IEC has direct participation in this study, written notification regarding his or her 
abstinence from voting must also be obtained. Those Americas sites unwilling to provide names
and titles of all members due to privacy and conflict of interest concerns should instead provide a 
Federal Wide Assurance Number or comparable number assigned by the Department of Health 
and Human Services.
The Sponsor or designee will supply relevant documents for submission to the respective IRB or 
IEC for the protocol’s review and approval. This protocol, the Investigator’s Brochure, a copy of 
the informed consent form, and, if applicable, participant recruitment materials and/or 
advertisements and other documents required by all applicable laws and regulations, must be 
submitted to a central or local IRB or IEC for approval. The IRB’s or IEC’s written approval of 
the protocol and participant informed consent must be obtained and submitted to the Sponsor or 
designee before commencement of the study (ie, before shipment of the Sponsor-supplied drug 
or study specific screening activity). The IRB or IEC approval must refer to the study by exact 
protocol title, number, and version date; identify versions of other documents (eg, informed 
consent form) reviewed; and state the approval date. The Sponsor will ship drug/notify site once 
the Sponsor has confirmed the adequacy of site regulatory documentation and, when applicable, 
the Sponsor has received permission from competent authority to begin the study. Until the site 
receives drug/notification no protocol activities, including screening, may occur.
Sites must adhere to all requirements stipulated by their respective IRB or IEC. This may include 
notification to the IRB or IEC regarding protocol amendments, updates to the informed consent 
form, recruitment materials intended for viewing by participants, local safety reporting 
requirements, reports and updates regarding the ongoing review of the study at intervals 
specified by the respective IRB or IEC, and submission of the Investigator’s final status report to 
IRB or IEC. All IRB and IEC approvals and relevant documentation for these items must be 
provided to the Sponsor or its designee.
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Participant incentives should not exert undue influence for participation. Payments to 
participants must be approved by the IRB or IEC and Sponsor.
13.2
Participant Information, Informed Consent, and Participant Authorization
Written consent documents will embody the elements of informed consent as described in the 
Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all 
applicable laws and regulations. The informed consent form, participant authorization form (if 
applicable), and participant information sheet (if applicable) describe the planned and permitted 
uses, transfers, and disclosures of the participant’s personal and personal health information for 
purposes of conducting the study. The informed consent form and the participant information 
sheet (if applicable) further explain the nature of the study, its objectives, and potential risks and 
benefits, as well as the date informed consent is given. The informed consent form will detail the 
requirements of the participant and the fact that he or she is free to withdraw at any time without 
giving a reason and without prejudice to his or her further medical care.
The Investigator is responsible for the preparation, content, and IRB or IEC approval of the 
informed consent form and, if applicable, the participant authorization form. The informed 
consent form, participant authorization form (if applicable), and participant information sheet (if 
applicable) must be approved by both the IRB or IEC and the Sponsor prior to use.
The informed consent form, participant authorization form (if applicable), and participant 
information sheet (if applicable) must be written in a language fully comprehensible to the 
prospective participant. It is the responsibility of the Investigator to explain the detailed elements 
of the informed consent form, participant authorization form (if applicable), and participant 
information sheet (if applicable) to the participant. Information should be given in both oral and 
written form whenever possible and in the manner deemed appropriate by the IRB or IEC. In the 
event the participant is not capable of rendering adequate written informed consent, then the 
participant’s legally acceptable representative may provide such consent for the participant in 
accordance with applicable laws and regulations.
The participant, or the participant’s legally acceptable representative, must be given ample 
opportunity to: (1) inquire about details of the study, and (2) decide whether or not to participate 
in the study. If the participant, or the participant’s legally acceptable representative, determines 
he or she will participate in the study, then the informed consent form and participant 
authorization form (if applicable) must be signed and dated by the participant, or the 
participant’s legally acceptable representative, at the time of consent and prior to the participant 
entering into the study. The participant or the participant’s legally acceptable representative 
should be instructed to sign using their legal names, not nicknames, using blue or black ballpoint 
ink. The Investigator must also sign and date the informed consent form and participant 
authorization (if applicable) at the time of consent and prior to participant entering into the study; 
however, the Sponsor may allow a designee of the Investigator to sign to the extent permitted by 
applicable law.
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Once signed, the original informed consent form, participant authorization form (if applicable), 
and participant information sheet (if applicable) will be stored in the Investigator’s site file. The
Investigator must document the date the participant signs the informed consent in the 
participant’s medical record. Copies of the signed informed consent form, the signed participant 
authorization form (if applicable), and participant information sheet (if applicable) shall be given 
to the participant.
All revised informed consent forms must be reviewed and signed by relevant participants or the 
relevant participant’s legally acceptable representative in the same manner as the original 
informed consent. The date the revised consent was obtained should be recorded in the 
participant’s medical record, and the participant should receive a copy of the revised informed 
consent form.
13.3
Participant Confidentiality
The Sponsor and designees affirm and uphold the principle of the participant’s right to protection 
against invasion of privacy. Throughout this study, a participant’s source data will only be linked 
to the Sponsor’s clinical study database or documentation via a unique identification number. As 
permitted by all applicable laws and regulations, limited participant attributes, such as sex, age, 
or date of birth, and participant initials may be used to verify the participant and accuracy of the 
participant’s unique identification number.
To comply with ICH Guidelines for GCP and to verify compliance with this protocol, the 
Sponsor requires the Investigator to permit its monitor or designee’s monitor, representatives 
from any regulatory authority (eg, FDA, Medicines and Healthcare products Regulatory Agency, 
PMDA), the Sponsor’s designated auditors, and the appropriate IRBs and IECs to review the 
participant’s original medical records (source data or documents), including, but not limited to, 
laboratory test result reports, ECG reports, admission and discharge summaries for hospital 
admissions occurring during a participant’s study participation, and autopsy reports. Access to a 
participant’s original medical records requires the specific authorization of the participant as part 
of the informed consent process (see Section 13.2).
Copies of any participant source documents that are provided to the Sponsor must have certain 
personally identifiable information removed (ie, participant name, address, and other identifier 
fields not collected on the participant’s CRF).
13.4
Publication, Disclosure, and Clinical Study Registration Policy
13.4.1
Publication and Disclosure
The Investigator is obliged to provide the Sponsor with complete test results and all data derived 
by the Investigator from the study. During and after the study, only the Sponsor may make study 
information available to other study Investigators or to regulatory agencies, except as required by 
law or regulation. Except as otherwise allowable in the clinical study site agreement, any public 
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disclosure (including publicly accessible websites) related to the protocol or study results, other 
than study recruitment materials and/or advertisements, is the sole responsibility of the Sponsor.
The Sponsor may publish any data and information from the study (including data and 
information generated by the Investigator) without the consent of the Investigator. Manuscript 
authorship for any peer-reviewed publication will appropriately reflect contributions to the 
production and review of the document. All publications and presentations must be prepared in 
accordance with this section and the Clinical Study Site Agreement. In the event of any 
discrepancy between the protocol and the Clinical Study Site Agreement, the Clinical Study Site 
Agreement will prevail.
13.4.2
Clinical Study Registration 
In order to ensure that information on clinical trials reaches the public in a timely manner and to 
comply with applicable laws, regulations and guidance, Takeda will, at a minimum register all 
interventional clinical trials it Sponsors anywhere in the world on ClinicalTrials.gov and/or other 
publicly accessible websites before start of study, as defined in Takeda Policy/Standard. Takeda 
contact information, along with Investigator’s city, state (for Americas / United States
Investigators), country, and recruiting status will be registered and available for public viewing. 
For some registries, Takeda will assist callers in locating study sites closest to their homes by 
providing the Investigator name, address, and phone number to the callers requesting trial 
information. Once participants receive Investigator contact information, they may call the site 
requesting enrollment into the trial. The investigative sites are encouraged to handle the trial 
inquiries according to their established participant screening process. If the caller asks additional 
questions beyond the topic of trial enrollment, they should be referred to the Sponsor.
Any Investigator who objects to the Sponsor providing this information to callers must provide 
the Sponsor with a written notice requesting that their information not be listed on the registry 
site.
13.4.3
Clinical Study Results Disclosure 
Takeda will post the results of clinical studies on ClinicalTrials.gov or other publicly accessible 
websites, as required by Takeda Policy/Standard, applicable laws and/or regulations.
13.5
Insurance and Compensation for Injury
Each participant in the study must be insured in accordance with the regulations applicable to the 
site where the participant is participating. If a local underwriter is required, then the Sponsor or 
Sponsor’s designee will obtain clinical study insurance against the risk of injury to study 
participants. Refer to the study site agreement regarding the Sponsor’s policy on participant 
compensation and treatment for injury. If the Investigator has questions regarding this policy, he 
or she should contact the Sponsor or Sponsor’s designee.
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14.0
ADMINISTRATIVE AND REFERENCE INFORMATION
14.1
Administrative Information
14.1.1
Study Contact Information 
Contact Type / Role
Contact
Serious adverse event and pregnancy reporting
Pharmacovigilance
Takeda Development Center Americas, Inc.
Fax:  +1 224-554-1052
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14.1.2
Investigator Agreement 
I confirm that I have read and that I understand this protocol, the Investigator’s Brochure, 
package insert and any other product information provided by the Sponsor. I agree to conduct 
this study in accordance with the requirements of this protocol and also to protect the rights, 
safety, privacy, and well-being of study participants in accordance with the following:

The ethical principles that have their origin in the Declaration of Helsinki.

International Council on Harmonisation, E6[R2] Good Clinical Practice: Consolidated 
Guideline.

All applicable laws and regulations, including, without limitation, data privacy laws and 
regulations.

Regulatory requirements for reporting serious adverse events defined in Section 10.2.9 of this 
protocol.

Terms outlined in the study site agreement.

Responsibilities of the Investigator (Appendix A).
I further authorize that my personal information may be processed and transferred in accordance 
with the uses contemplated in Appendix C of this protocol.
Signature of Investigator
Date
Investigator Name (print or type)
Investigator’s Title
Location of Facility (City, State/Provence)
Location of Facility (Country)
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14.1.3
Study-Related Responsibilities 
The Sponsor will perform all study-related activities with the exception of those identified in the 
Study-Related Responsibilities template. The vendors identified for specific study-related 
activities will perform these activities in full or in partnership with the Sponsor.
14.1.4
List of Abbreviations
AE
Adverse event
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
AUC
Area under the concentration-time curve
AUC12
Area under the concentration-time curve, from time 0 to 12
AUC
Area under the concentration-time curve, from time 0 to infinity
AUCextrap%
Percent of AUCextrapolated
AUClast
Area under the concentration-time curve, from time 0 to the last quantifiable 
concentration.
BID
Twice daily doses
BMI
Body mass index
bpm
Beats per minute
C12
Concentration at 12 hours postdose
CFR
Code of Federal Regulations
CI
Confidence interval
CL/F
Apparent clearance after oral administration
cm
Centimeter
Cmax
Maximum observed concentration 
CMV
Cytomegalovirus
COVID-19
Coronavirus disease 2019
CPAP
Clinical Pharmacology Analysis Plan
CRF
Case report form
CRU
Clinical Research Unit
CSR
Clinical study report
CV
Coefficient of variance
DNA
Deoxyribonucleic acid 
ECG
Electrocardiogram
EMA
European Medicines Agency
FSH
Follicle stimulating hormone
FT4
Free thyroxine
g
Gram
GCP
Good Clinical Practice
GI
Gastrointestinal
GMR
Geometric mean ratio
HBsAg
Hepatitis B surface antigen
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hCG
Human chorionic gonadotropin
HCV
Hepatitis C virus 
HIV
Human immunodeficiency virus
ICF
Informed Consent Form
ICH
International Council for Harmonisation
ID
Investigational drug
IEC
Independent Ethics Committee
IRB
Institutional Review Board
kg
Kilogram
L
Liter
LFT
Liver function test
m2
Meters squared
MedDRA®
Medical Dictionary for Regulatory Activities®
mg
Milligram
mL
Milliliter
mmHg
Millimeter of mercury
msec
Millisecond
NCA
Non-compartmental analysis
PCS
Potentially clinically significant
PK
Pharmacokinetic(s)
PMDA
Pharmaceuticals and Medical Devices Agency 
QTc
Corrected QT interval
QTcF
QT interval corrected for heart rate using Fridericia’s formula
SAE
Serious adverse event
SAP
Statistical analysis plan
SD
Standard deviation
SUSAR
Suspected unexpected serious adverse reaction
t½z
Terminal disposition phase half-life
TEAE
Treatment-emergent adverse event
tlag
Lag time to first quantifiable concentration in plasma
tmax
Time to first occurrence of Cmax
TSH
Thyroid stimulating hormone
ULN
Upper limit of normal
US
United States
USA
United States of America
Vz/F
Apparent volume of distribution during the terminal disposition phase after oral 
administration
λz
Terminal disposition phase rate constant
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15.0
DATA HANDLING AND RECORDKEEPING
The full details of procedures for data handling will be documented in the Data Management 
Plan. AEs, medical history, and concurrent conditions will be coded using the MedDRA®. Drugs 
will be coded using the World Health Organization Drug Dictionary.
15.1
CRFs (Electronic and Paper)
Celerion standard CRFs will be supplied. CRFs are produced, stored electronically, and are 
available to the designated study team members. Each CRF is reviewed and signed by the 
Investigator. The final signed CRFs are provided to the Sponsor in the format as decided upon 
between Celerion and the Sponsor (eg, electronically, compact disc, flashdrive, Secure File 
Transfer Protocol). This will be documented in the Data Management Plan (if applicable).
After completion of the entry process, computer logic checks will be run to identify items, such 
as inconsistent dates, missing data, and questionable values. Queries may be issued by Takeda 
personnel (or designees) and will be answered by the site. 
Corrections are recorded in an audit trail that captures the old information, the new information, 
identification of the person making the correction, the date the correction was made, and the 
reason for change. Reasons for significant corrections should additionally be included. 
The principal Investigator must review the CRFs for completeness and accuracy and must sign 
and date the appropriate CRFs as indicated. Furthermore, the Investigator must retain full 
responsibility for the accuracy and authenticity of all data entered on the CRFs.
After the lock of the clinical study database, any change of, modification of, or addition to the 
data on the CRFs should be made by the Investigator with use of change and modification 
records of the CRFs. The principal Investigator must review the data change for completeness 
and accuracy, and must sign and date. 
CRFs will be reviewed for completeness and acceptability at the study site during periodic visits 
by study monitors. The Sponsor or its designee will be permitted to review the participant’s 
medical and hospital records pertinent to the study to ensure accuracy of the CRFs. The 
completed CRFs are the sole property of the Sponsor and should not be made available in any 
form to third parties, except for authorized representatives of appropriate governmental health or 
regulatory authorities, without written permission of the Sponsor.
15.2
Record Retention
The Investigator agrees to keep the records stipulated in Section 15.1 and those documents that 
include (but are not limited to) the study-specific documents, the identification log of all 
participating participants, medical records, temporary media such as thermal sensitive paper, 
source worksheets, all original signed and dated informed consent forms, participant 
authorization forms regarding the use of personal health information (if separate from the 
informed consent forms), electronic copy of CRFs, including the audit trail, and detailed records 
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of drug disposition to enable evaluations or audits from regulatory authorities, the Sponsor or its 
designees. Any source documentation printed on degradable thermal sensitive paper should be 
photocopied by the site and filed with the original in the participant’s chart to ensure long-term 
legibility. Furthermore, ICH E6 Section 4.9.5 requires the Investigator to retain essential 
documents specified in ICH E6 (Section 8) until at least 2 years after the last approval of a 
marketing application for a specified drug indication being investigated or, if an application is 
not approved, until at least 2 years after the investigation is discontinued and regulatory 
authorities are notified. In addition, ICH E6 Section 4.9.5 states that the study records should be 
retained until an amount of time specified by applicable regulatory requirements or for a time 
specified in the Clinical Study Site Agreement between the Investigator and Sponsor.
Refer to the Clinical Study Site Agreement for the Sponsor’s requirements on record retention. 
The Investigator and the head of the institution should contact and receive written approval from 
the Sponsor before disposing of any such documents.
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16.0
REFERENCES
1. Chulay et al., Development of novel benzimidazole riboside compounds for treatment of 
cytomegalovirus disease. In Antiviral Chemotherapy 5: New Directions for Clinical 
Application and Research (Advances in Experimental Medicine and Biology, volume. 458). 
Edited by J Mill, P Volberding & L Corey. Plenum Publishing Corporation: New York. 
1999.
2. Williams, et al. In vitro activities of benzimidazole d- and l-ribonucleosides against 
herpesviruses. Antimicrob. Agents Chemother. 2003;47:2186–2192.
3. Biron et al., Potent and selective inhibition of human cytomegalovirus replication by 
1263W94, a benzimidazole L-riboside with a unique mode of action Antimicrob. Agents 
Chemother. 2002;46:2365-2372.
4. Drew et al., Maribavir sensitivity of cytomegalovirus isolates resistant to ganciclovir, 
cidofovir or foscarnet J Clin Virol. 2006;37(2):124-7. doi: 10.1016/j.jcv.2006.07.010. Epub 
2006 Sep 8.
5. Kern et al., Oral treatment of murine cytomegalovirus infections with ether lipid esters of 
cidofovir. Antimicrob. Agents Chemother. 2004;48:3516–3522.
6. Krosky et al., The human cytomegalovirus UL97 protein kinase, an antiviral drug target, is 
required at the stage of nuclear egress. J. Virol. 2003;77:905–914.
7. Wolf et al., Distinct and separate roles for herpesvirus-conserved UL97 kinase in 
cytomegalovirus DNA synthesis and encapsidation Proc. Natl Acad. Sci. USA, 
2001;98(4)1895–1900.
8. LIVTENCITY (maribavir milled tablets): Highlights of Prescribing Information 
LIVTENCITY (maribavir) Label (fda.gov): November 2021.
9. Goldwater et al., Priors in Bayesian learning of phonological rules. In Proceedings of the 7th 
Meeting of the ACL Special Interest Group in Computational Phonology: Current Themes in 
Computational Phonology and Morphology, pages 35–42. Association for Computational 
Linguistics. 2004.
10. Wang L et al., Phase I safety and pharmacokinetic trials of 1263W94, a novel oral anti-
human cytomegalovirus agent, in healthy and human immunodeficiency virus-infected 
subject. Antimicrob. Agents Chemother. 2003;47:1334–1342.
11. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance 
for Industry: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical 
Pharmacology Considerations. (Draft Feb 2019). Available at: 
https://www.fda.gov/media/121313/download.
12. European Medicines Agency. Committee for Human Medicinal Products (CHMP): Guideline 
on the Investigation of Drug Interactions (21 June 2012. CPMP/EWP/560/95/Rev. 1 Corr. 2), 
Available at:  https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-
investigation-drug-interactions-revision-1_en.pdf.
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13. Japan Pharmaceuticals and Medical Devices Agency (PMDA). Guideline for Bioequivalence 
Studies of Generic Products. English translation of Attachment 1 of Division-Notification 
0229 No. 10 of the Pharmaceutical and Food Safety Bureau (February 29, 2012). Available 
at: http://www.nihs.go.jp/drug/be-guide(e)/Generic/GL-E_120229_BE.pdf.
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17.0
APPENDICES
Appendix A
Responsibilities of the Investigator
Clinical research studies sponsored by the Sponsor are subject to ICH GCP and all the applicable 
local laws and regulations. The responsibilities imposed on Investigators by the FDA are 
summarized in the “Statement of Investigator” (Form FDA 1572), which must be completed and 
signed before the Investigator may participate in this study.
The Investigator agrees to assume the following responsibilities by signing a Form FDA 1572:
1. Conduct the study in accordance with the protocol.
2. Personally conduct or supervise the staff that will assist in the protocol.
3. If the Investigator/institution retains the services of any individual or party to perform trial-
related duties and functions, the Investigator/institution should ensure that this individual or 
party is qualified to perform those trial-related duties and functions and should implement 
procedures to ensure the integrity of the trial-related duties and functions performed and any 
data generated.
4. Ensure that study related procedures, including study specific (nonroutine/nonstandard panel) 
screening assessments are NOT performed on potential participants, prior to the receipt of 
written approval from relevant governing bodies/authorities.
5. Ensure that all colleagues and employees assisting in the conduct of the study are informed 
of these obligations.
6. Secure prior approval of the study and any changes by an appropriate IRB/IEC that conform 
to 21 CFR Part 56, ICH, and local regulatory requirements.
7. Ensure that the IRB/IEC will be responsible for initial review, continuing review, and 
approval of the protocol. Promptly report to the IRB/IEC all changes in research activity and 
all anticipated risks to participants. Make at least yearly reports on the progress of the study 
to the IRB/IEC, and issue a final report within 3 months of study completion.
8. Ensure that requirements for informed consent, as outlined in 21 CFR Part 50, ICH and local 
regulations, are met.
9. Obtain valid informed consent from each participant who participates in the study, and 
document the date of consent in the participant’s medical chart. Valid informed consent is the 
most current version approved by the IRB/IEC. Each informed consent form should contain a 
participant authorization section that describes the uses and disclosures of a participant’s 
personal information (including personal health information) that will take place in 
connection with the study. If an informed consent form does not include such a participant 
authorization, then the Investigator must obtain a separate participant authorization form 
from each participant or the participant’s legally acceptable representative.
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10. Prepare and maintain adequate case histories of all persons entered into the study, including 
CRFs, hospital records, laboratory results, etc, and maintain these data for a minimum of 
2 years following notification by the Sponsor that all investigations have been discontinued 
or that the regulatory authority has approved the marketing application. The Investigator 
should contact and receive written approval from the Sponsor before disposing of any such 
documents.
11. Allow possible inspection and copying by the regulatory authority of GCP-specified essential 
documents.
12. Maintain current records of the receipt, administration, and disposition of Sponsor-supplied 
drugs, and return all unused Sponsor-supplied drugs to the Sponsor. 
13. Report adverse reactions to the Sponsor promptly. In the event of an SAE, notify the Sponsor 
within 24 hours.
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Appendix B
Elements of the Participant Informed Consent
In seeking informed consent, the following information shall be provided to each participant:
1. A statement that the study involves research.
2. An explanation of the purposes of the research.
3. The expected duration of the participant’s participation.
4. A description of the procedures to be followed, including invasive procedures.
5. The identification of any procedures that are experimental.
6. The estimated number of participants involved in the study.
7. A description of the participant’s responsibilities.
8. A description of the conduct of the study.
9. A statement describing the treatment(s) and the probability for random assignment to each 
treatment.
10. A description of the possible side effects of the treatment that the participant may receive.
11. A description of any reasonably foreseeable risks or discomforts to the participant and, when 
applicable, to an embryo, fetus, or nursing infant.
12. A description of any benefits to the participant or to others that reasonably may be expected 
from the research. When there is no intended clinical benefit to the participant, the participant 
should be made aware of this.
13. Disclosures of appropriate alternative procedures or courses of treatment, if any, that might 
be advantageous to the participant and their important potential risks and benefits.
14. A statement describing the extent to which confidentiality of records identifying the 
participant will be maintained, and a note of the possibility that regulatory agencies, 
auditor(s), IRB/IEC, and the monitor may inspect the records. By signing a written informed 
consent form, the participant or the participant’s legally acceptable representative is 
authorizing such access.
15. For research involving more than minimal risk, an explanation as to whether any 
compensation and an explanation as to whether any medical treatments are available if injury 
occurs and, if so, what they consist of or where further information may be obtained.
16. The anticipated prorated payment(s), if any, to the participant for participating in the study.
17. The anticipated expenses, if any, to the participant for participating in the study.
18. An explanation of whom to contact for answers to pertinent questions about the research 
(Investigator), participant’s rights, and IRB/IEC and whom to contact in the event of a
research-related injury to the participant.
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19. A statement that participation is voluntary, that refusal to participate will involve no penalty 
or loss of benefits to which the participant otherwise is entitled, and that the participant or the 
participant’s legally acceptable representative may discontinue participation at any time 
without penalty or loss of benefits to which the participant is otherwise entitled.
20. The consequences of a participant’s decision to withdraw from the research and procedures 
for orderly termination of participation by the participant.
21. A statement that the participant or the participant’s legally acceptable representative will be 
informed in a timely manner if information becomes available that may be relevant to the 
participant’s willingness to continue participation in the study.
22. The foreseeable circumstances or reasons under which the participant’s participation in the 
study may be terminated.
23. A written participant authorization (either contained within the informed consent form or
provided as a separate document) describing to the participant the contemplated and 
permissible uses and disclosures of the participant’s personal information (including personal 
health information) for purposes of conducting the study. The participant authorization must 
contain the following statements regarding the uses and disclosures of the participant’s 
personal information:
a) that personal information (including personal health information) may be processed by or 
transferred to other parties in other countries for clinical research and safety reporting 
purposes, including, without limitation, to the following: (1) Takeda, its affiliates, and 
licensing partners; (2) business partners assisting Takeda, its affiliates, and licensing 
partners; (3) regulatory agencies and other health authorities; and (4) IRBs/IECs;
b) it is possible that personal information (including personal health information) may be 
processed and transferred to countries that do not have data protection laws that offer 
participants the same level of protection as the data protection laws within this country; 
however, Takeda will make every effort to keep your personal information confidential, 
and your name will not be disclosed outside the clinic unless required by law;
c) that personal information (including personal health information) may be added to 
Takeda’s research databases for purposes of developing a better understanding of the 
safety and effectiveness of the ID(s), studying other therapies for patients, developing a 
better understanding of disease, and improving the efficiency of future clinical studies;
d) that participants agree not to restrict the use and disclosure of their personal information 
(including personal health information) upon withdrawal from the study to the extent that 
the restricted use or disclosure of such information may impact the scientific integrity of 
the research; and
e) that the participant’s identity will remain confidential in the event that study results are 
published.
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24. Female participants of childbearing potential (eg, nonsterilized, premenopausal female 
participants) who are sexually active must use highly effective contraception (as defined in 
the informed consent) from signing the informed consent and throughout the duration of the 
study, and for 1 month after the last dose of the ID. If a participant is found to be pregnant 
during study, ID will be discontinued. 
25. Male participants must use an effective contraception (as defined in the informed consent) 
from signing the informed consent throughout the duration of the study and for 3 months 
after the last dose of the ID.
26. A statement that clinical trial information from this trial will be publicly disclosed in a 
publicly accessible website, such as ClinicalTrials.gov.
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Appendix C
Investigator Consent to the Use of Personal Information 
Takeda will collect and retain personal information of Investigator, including his or her name, 
address, and other personally identifiable information. In addition, Investigator’s personal 
information may be transferred to other parties located in countries throughout the world (eg, the 
United Kingdom, United States, and Japan), including the following:

Takeda, its affiliates, and licensing partners.

Business partners assisting Takeda, its affiliates, and licensing partners.

Regulatory agencies and other health authorities.

IRBs and IECs.
Investigator’s personal information may be retained, processed, and transferred by Takeda and 
these other parties for research purposes including the following:

Assessment of the suitability of Investigator for the study and/or other clinical studies.

Management, monitoring, inspection, and audit of the study.

Analysis, review, and verification of the study results.

Safety reporting and pharmacovigilance relating to the study.

Preparation and submission of regulatory filings, correspondence, and communications to 
regulatory agencies relating to the study.

Preparation and submission of regulatory filings, correspondence, and communications to 
regulatory agencies relating to other medications used in other clinical studies that may 
contain the same chemical compound present in the ID.

Inspections and investigations by regulatory authorities relating to the study.

Self-inspection and internal audit within Takeda, its affiliates, and licensing partners.

Archiving and audit of study records.

Posting Investigator site contact information, study details and results on publicly accessible 
clinical trial registries, databases, and websites.
Investigator’s personal information may be transferred to other countries that do not have data 
protection laws that offer the same level of protection as data protection laws in Investigator’s 
own country.
Investigator acknowledges and consents to the use of his or her personal information by Takeda 
and other parties for the purposes described above.
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Appendix D
Pregnancy and Contraception
Contraception and Pregnancy Avoidance Procedure
Male Participants
From signing of informed consent, throughout the duration of the study, and for 3 months after 
last dose of the ID, nonsterilized** male participants who are sexually active with a female 
partner of childbearing potential* must use barrier contraception (eg, condom with or without 
spermicidal cream or jelly). In addition, they must be advised not to donate sperm during this 
period.
Female Participants and Their Male Partners
From signing of informed consent, throughout the duration of the study, and for 1 month after 
last dose of the ID, female participants of childbearing potential* who are sexually active with a 
nonsterilized male partner** must use a highly effective/effective method of contraception (from 
the list below). In addition they must be advised not to donate ova during this period.
Definitions and Procedures for Contraception and Pregnancy Avoidance
The following definitions apply for contraception and pregnancy avoidance procedures.
* A woman is considered a woman of childbearing potential, ie fertile, following menarche and 
until becoming post-menopausal unless permanently sterile. Permanent sterilization methods 
include hysterectomy, and bilateral oophorectomy. A postmenopausal state is defined as no 
menses for 12 months without an alternative medical cause. A high FSH level in the 
postmenopausal range (FSH >40 IU/L) may be used to confirm a post-menopausal state in 
younger women (eg, those <45 year old) or women who are not using hormonal contraception or 
hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single 
FSH measurement is insufficient.
** Sterilized males should be at least 1 year post-bilateral vasectomy and have confirmed that 
they have obtained documentation of the absence of sperm in the ejaculate or have had bilateral 
orchidectomy.
The following procedures apply for contraception and pregnancy avoidance.
1. Highly effective methods of contraception are defined as “those, alone or in combination, 
that result in a low failure rate (ie, less than 1% failure rate per year when used consistently 
and correctly). In this study, where medications and devices containing hormones are 
included, the only acceptable methods of contraception are: 
Non-Hormonal Methods: 
–
Intrauterine device.
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–
Bilateral tubal occlusion.
–
Vasectomy, provided that partner is the sole sexual partner of the study participant 
and that the vasectomised partner has received medical assessment of the surgical 
success.
–
True sexual abstinence, only if this is in line with the preferred and usual lifestyle of 
the participant. True abstinence is defined as refraining from heterosexual intercourse 
during the entire period of the study, from 1 month prior to the first dose of the ID
until 1 month after last dose of the ID for female participants of childbearing 
potential* and 3 months after the last dose of the ID for male participants.
Hormonal Methods:
–
Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation initiated at least 3 months prior to the first dose of the ID OR 
combined with a barrier method (male condom, female condom or diaphragm) if for 
shorter duration until she has been on contraceptive for 3 months;
Oral
Intravaginal (eg, ring)
Transdermal
–
Progestogen-only hormonal contraception associated with inhibition of ovulation1 
initiated at least 3 months prior to the first dose of the ID OR combined with a barrier 
method (male condom, female condom or diaphragm) if shorter till she has been on 
contraceptive for 3 months;
Oral
Injectable
Implantable
Intrauterine device
2. In addition, effective methods of contraception (there may be a higher than 1% failure rate) 
are: 
-
Female participant: Double-barrier method (contraceptive sponge, diaphragm or cervical 
cap with spermicidal jellies or creams PLUS male condom).
-
Female participant: Progestogen only hormonal contraception, where inhibition of 
ovulation is not the primary mode of action PLUS condom with or without spermicide.
-
Male participant with female partner of childbearing potential: A barrier method 
(condom with or without spermicidal cream or jelly).
3. Unacceptable methods of contraception are:
-
Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods).
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-
Spermicides only.
-
Withdrawal.
-
No method at all.
-
Use of female and male condoms together.
-
Cap/diaphragm/sponge without spermicide and without condom.
-
Sexual abstinence is NOT an acceptable method of contraception, unless it is true sexual 
abstinence.
4. Participants will be provided with information on highly effective/effective methods of 
contraception as part of the participant informed consent process and will be asked to sign a 
consent form stating that they understand the requirements for avoidance of pregnancy, 
donation of ova, and sperm donation during the course of the study.
5. During the course of the study, regular serum human chorionic gonadotropin (hCG) 
pregnancy tests will be performed only for women of childbearing potential and all 
participants (male and female) will receive continued guidance with respect to the avoidance 
of pregnancy and sperm donation as part of the study procedures. Such guidance should 
include a reminder of the following:
a) contraceptive requirements of the study
b) reasons for use of barrier methods (ie, condom) in males with pregnant partners
c) assessment of participant compliance through questions such as
i. Have you used the contraception consistently and correctly since the last visit?
ii. Have you forgotten to use contraception since the last visit?
iii. Are your menses late (even in women with irregular or infrequent menstrual cycles a 
pregnancy test must be performed if the answer is “yes”)
iv. Is there a chance you could be pregnant?
6. In addition to a negative serum hCG pregnancy test at the screening visit, female participants 
of childbearing potential must also have confirmed menses in the month before first dose of 
the ID (no delayed menses; with the exception of female participants using a protocol 
acceptable contraception method that has a known side effect of delayed or irregular 
menses), and, a negative serum hCG pregnancy test prior to receiving any dose of the ID. In
addition, participants must also have a negative serum hCG pregnancy test within 28 days 
prior to receiving first dose of the ID.
General Guidance With Respect to the Avoidance of Pregnancy
Such guidance should include a reminder of the following:

contraceptive requirements of the study.
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
reasons for use of barrier methods (ie, condom) in males with pregnant partners.

assessment of participant compliance through questions such as:
–
Have you used the contraception consistently and correctly since the last visit?
–
Have you forgotten to use contraception since the last visit?
–
Are your menses late (even in women with irregular or infrequent menstrual 
cycles a pregnancy test must be performed if the answer is “yes”)
–
Is there a chance you could be pregnant?
Pregnancy
If a female participant is found to be pregnant during the study she should be withdrawn and any 
sponsor-supplied drug should be immediately discontinued. In addition, any pregnancies in the 
partner of a male participant during the study or for 3 months after the last dose, should also be 
recorded following authorization from the participant’s partner. 
If the female participant and/or female partner of a male participant agrees to the primary care 
physician being informed, the Investigator should notify the primary care physician of her or her 
male partner (ie, male participant) participation in a clinical study at the time she became 
pregnant and provide details of the ID the female participant or her male partner (ie, male 
participant) received.
All pregnancies, including female partners of male participants, in participants on active ID 
(including comparator, if applicable) will be followed up to final outcome, using the pregnancy 
form. Pregnancies will remain blinded to the study team. The outcome, including any premature 
termination, must be reported to the Sponsor. An evaluation after the birth of the child will also 
be conducted.
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