Conditions: Vulvovaginal Candidiasis Candida Infection Vaginal Candidiasis
Keywords: VVC Thrush BREXAFEMME Candidiasis Vaginal Yeast Yeast Infection Lactating Fungal Disease Fungal Infection
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: yes

Brief summary:
This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening

Detailed description:
This was a Phase 1 study designed to evaluate the pharmacokinetics of ibrexafungerp after administration of two oral doses in lactating women to determine whether ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and plasma of lactating women.

Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H). Participants received both doses on site. Participants were admitted to the clinic on Day 1 and discharged on Day 5, after the 108-hour procedures were completed.

Arms:
arm 1: Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)

Interventions: intervention 1: Ibrexafungerp
Intervention descriptions: intervention 1: Ibrexafungerp Oral Tablet

Protocol document:
Prot_000.pdf: 
1. 
TITLE PAGE 
 
SCYNEXIS, Inc. 
Clinical Trial Protocol 
An Open-Label Pharmacokinetic Study in Healthy Lactating 
Women after Two Oral Doses of Ibrexafungerp Administered on 
a Single Day 
SCYNEXIS Protocol Number SCY-078-121 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Protocol Version 1.0: 
 
11-July-2022 
Protocol Version 2.0 
(Amendment 01) 
 
04-October-2022 
Protocol Version 3.0 
(Amendment 02) 
 
26-May-2023 
Protocol Version 4.0 
(Amendment 03) 
 
13-March-2024 
US IND Number 107,521 
STATEMENT OF CONFIDENTIALITY 
The information in this document contains trade secrets and commercial information that are privileged or confidential 
and may not be disclosed unless such disclosure is required by federal or state law or regulations. In any event, persons 
to whom the information is disclosed must be informed that the information is privileged or confidential and may not be 
further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you 
which is indicated as privileged or confidential. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 2 
1.1. 
Version 4.0 Summary of Changes (13-March-2024): 
Change Made 
Location in Protocol 
Sponsor contact information updated 
Section 2.0 Contact Information, Section 3.0 
Protocol Approvals 
Interim analysis related text added 
Synopsis, Section 7.2.2 Rationale for Interim 
Analysis, Section 9.1 Overall Study Design, 
Section 9.2 Number of Participants, Section 
10.2 Participant Withdrawal Criteria, Section 
15.2 Sample Size Determination, and Section 
15.5 Interim Analysis 
Footnote “f” was revised to remove “serum” 
from the alcohol screening text. The site’s 
standard for alcohol screening will be utilized. 
An “X” was added to the Day 5 (Post-Study) 
weight measurements assessment to align 
with the corresponding text in Section 11.7.5 
(Day 5 (Post-Study)) 
Table 5 Schedule of Assessments 
Reference to the site’s smoking policy 
removed 
Section 11.3.3 Smoking Restrictions 
The caloric intake of standard meals was 
increased to accommodate the needs of 
lactating women (average of ~300 extra 
calories per day). 
Section 11.5.1 Standard Meal 
The prestudy screening window has been 
modified from 2 weeks to 4 weeks, which 
aligns with the Duration of Treatment text 
(Synopsis and Section 9.1 (Overall Study 
Design)) of 4 to 5 weeks. 
Section 11.7.1 Prestudy Screening Day -14 
Day -28 to Day -1, Table 5 Schedule of 
Assessments (Footnote “a”) 
The predose safety labs and serum pregnancy 
test window was modified from 24 hours 
predose to 24-48 hours predose. 
Section 11.7.2 (Predose (Prior to Day 1 
Morning Dosing) 
Last sentence was removed to clarify that all 
study medication will be dispensed while 
participants are domiciled. 
Section 12.1 Study Drug 
The calculation for M/P has been added. 
Synopsis, Section 15.4 Pharmacokinetic 
Analysis 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 3 
1.2. 
Version 3.0 Summary of Changes (26-May-2023): 
Change Made 
Location in Protocol 
Clinical site information removed. Project 
Manager information updated. CRO project 
manager information combined. 
Section 2.0 Contact Information 
Site information removed and placeholders 
added 
Synopsis and Investigator’s Agreement 
Statement 
Study center(s) field updated to “One (1) to 2 
sites”, Country field updated, and Study 
period (years) field dates updated 
Synopsis 
Inclusion criterion #4 updated for consistency 
purposes and to include “acceptance of bottle 
feeding”. 
Inclusion criterion #9 updated to include 
vaping. 
Section 10.1.1 Inclusion Criteria 
Herbal products allowed to increase breast 
milk production updated. 
Section 11.2 Prior and Concomitant 
Medications 
Added text indicating acceptance of bottle 
feeding prior to study start. 
Added text related to breast feeding 
restrictions if a participant discontinues early. 
Section 11.3.5 Breast Feeding 
“Clinical research unit” text added and SAE 
reporting window clarified to align with 
Appendix B text. 
Section 14.2.9 Reporting Adverse Events 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 4 
1.3. 
Version 2.0 Summary of Changes (04-October-2022): 
Change Made 
Location in Protocol 
Added text related to the benefits of 
breastfeeding compared to the risks of 
interruption of breastfeeding, including the 
potential for changes in milk supply and 
difficulty re-establishing breastfeeding after 
the study is completed. 
Section 7.2.1 Benefits and Risks of 
Breastfeeding and Section 9.4.1 Potential 
Risks  
Clarified the window prior and concomitant 
medication is 14 days prior to dosing (Day 1) 
and throughout the poststudy. 
Section 11.2 Prior and Concomitant 
Medications and Section 14.1.6.9 Adverse 
Event and Concomitant Medication 
Assessment 
Updated pre-dose safety lab and serum 
pregnancy sampling window extension to 
24hrs predose instead of 12hrs predose. 
 
Table 5 Schedule of Assessments and Section 
11.7.2 Predose (Prior to Day 1 Morning 
Dose) 
Added “serum pregnancy to have a sensitivity 
of at least 25 mIU/L.” 
Section 14.1.6.7 Pregnancy Screen 
Clarified the window for AEs and 
concomitant medications should be collected 
only through post study. 
Section 14.1.6.9 Adverse Event and 
Concomitant Medication Assessments 
Section 14.2.8 Recording Adverse Events 
Clarified serious adverse event information 
will be collected from time of informed 
through the poststudy visit. 
Section 14.2.8 Recording Adverse Events 
Clarified the vital signs <0 hours timepoint 
(pre-dose) acceptable time window may be 
performed up to 12 hours predose.  
Appendix A: Time Window for Serial 
Assessments 
 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 5 
2. 
CONTACT INFORMATION 
Study Medical Monitor 
Michelle Middle, MD 
Medical Director, Clinical Development 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Phone: +27.82.4934.621 
Email: michelle.middle@scynexis.com  
Clinical Pharmacologist 
M. Gail Murphy, MD 
Phase 1 Consultant 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Phone: +1.302.540.8725 
Email: gail.murphy@scynexis.com 
Pharmacokineticist & CRO 
Project Manager 
Michael S. Willett, PharmD, RAC 
President 
Ready Clinical, LLC 
P.O. Box 89504 
2501 S. Louise Avenue 
Sioux Falls, SD 57106-4325 
Mobile: 908-500-0902 
E-mail: michael.willett@readyclinical.com 
Sponsor 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Sponsor Program Director 
Michelle Middle, MD 
Medical Director, Clinical Development 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Phone: +27.82.4934.621 
Email: michelle.middle@scynexis.com 
Sponsor Project Manager 
Lisa Ratcliffe 
SCYNEXIS, Inc. 
Phase 1 Clinical Development Consultant 
for SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Phone: +1.917.902.6572 
Email: lisa.ratcliffe@bchrs.com 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 6 
3. 
PROTOCOL APPROVALS 
Sponsor’s Approval Signature Page 
PROTOCOL ID: SCY-078-121 
An Open-Label Pharmacokinetic Study in Healthy Lactating Women after Two 
Oral Doses of Ibrexafungerp Administered on a Single Day 
The protocol has been approved by SCYNEXIS, Inc. 
Sponsor’s Authorized Officer: 
 
 
 
Michelle Middle, MD 
Medical Director, Clinical Development 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302 
Phone: +27.82.4934.621 
Email: michelle.middle@scynexis.com 
 
Date 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 7 
 
 
Investigator’s Agreement Statement 
PROTOCOL ID: SCY-078-121 
An Open-Label Pharmacokinetic Study in Healthy Lactating Women after Two Oral Doses 
of Ibrexafungerp Administered on a Single Day 
I understand that all documentation provided to me by SCYNEXIS, Inc. or its designated 
representative(s) concerning this study that has not been published previously will be kept in the 
strictest confidence. This documentation includes the study protocol, Investigator’s Brochure, 
case report forms, and other scientific data. This study will not commence without the prior 
written approval of a properly constituted Institutional Review Board or Ethics Committee. No 
changes will be made to the study protocol without the prior written approval of SCYNEXIS, 
Inc. and the Institutional Review Board/Ethics Committee, except where necessary to eliminate 
an immediate hazard to the participant. All participants will provide a written informed consent 
prior to participation. 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I have read, understood, and agree 
to abide by all the conditions and instructions contained in this protocol, and in compliance with 
International Conference on Harmonization (ICH) guidelines, Good Clinical Practices (GCP), 
Safety Reporting obligations and any applicable local requirements. 
Principal Investigator’s Signature 
 
Date 
 
 
 
Print Principal Investigator’s Name 
 
Principal Investigator 
__________________ 
Site Name 
__________________ 
__________________ 
Site Address 
 
 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 8 
 
 
4. 
SYNOPSIS 
Name of Sponsor/Company: 
SCYNEXIS, Inc. 
Name of Investigational Product: 
Ibrexafungerp 
Name of Active Ingredient: 
Ibrexafungerp 
Protocol Number: 
SCY-078-121 
Phase: 1 
Country: US 
Title of Study: 
An Open-Label Pharmacokinetic Study in Healthy Lactating Women after Two Oral Doses of 
Ibrexafungerp Administered on a Single Day 
Study center(s): One (1) to 2 sites 
Studied period (years): 
Estimated date first patient enrolled: July 2023 
Estimated date last patient completed: July 2024 
Objectives: 
Primary Objective: 
• To determine whether ibrexafungerp is excreted in breast milk and if so, to characterize 
ibrexafungerp pharmacokinetics (PK) in the breast milk and plasma of lactating women. 
Secondary Objectives: 
• To calculate the potential infant exposure to ibrexafungerp if lactating women are treated with 
ibrexafungerp. 
• To characterize the safety and tolerability of ibrexafungerp in lactating women. 
Study Design: 
Ibrexafungerp is approved in the United States as a single day, two-dose therapy for women with 
vulvovaginal candidiasis (VVC). This is a Phase 1 study designed to determine whether this dose of 
ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk 
and plasma of lactating women. 
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp 
doses given 12 hours apart (Q12H). Participants will receive both doses on site. Participants will be 
admitted to the clinic on Day -1, and may be discharged on Day 5, after the 108-hour procedures are 
completed, at the discretion of the Investigator. 
Product, Dose, and Timing 
Study Day 
Ibrexafungerp 300-mg BID on Day 1  
1 
Safety will be monitored with laboratory and clinical evaluations: vital signs, physical examinations, 
and the collection of adverse events (AE) and concomitant medications. Breast milk and plasma PK 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 9 
 
 
samples will be obtained at selected intervals and time points pre-dose and post-dose for 
determination of ibrexafungerp concentrations. 
An interim analysis will be performed after 5 subjects have completed the study. 
Number of participants (planned): 
Up to 10 healthy lactating females who are at least 10 days postpartum with a fully established milk 
supply and are between the ages of 18 and 50 years at the time of screening. Participants who 
discontinue or are discontinued may be replaced to ensure that an adequate number of participants to 
achieve the study objectives, complete the study. 
Investigational Product, Dosage, and Mode of Administration: 
The study drug, ibrexafungerp citrate salt tablets, will be provided as oral 150-mg tablets, by the 
Sponsor. 
All participants will receive ibrexafungerp in two 300-mg (2 x150-mg tablets) oral doses given Q12H 
with food. 
Ibrexafungerp citrate salt tablets will be stored at room temperature in a secure and locked location in 
the clinical research unit. 
Duration of Treatment: 
The duration of study participation from pre-study through post-study safety monitoring will be 
approximately 4 to 5 weeks for participants. 
Criteria for evaluation: 
Pharmacokinetics: 
Breast milk will be obtained up to 108 hours post dose and blood samples will be obtained starting 
pre-dose the Day 1 morning dose until 108 hours post first dose of study drug for determination of 
ibrexafungerp concentrations. Sample time points are as follows: 
• Breast Milk:  complete expression of milk from both breasts (using a standard electric breast 
pump) will be obtained at the following timepoints and intervals: pre-dose, 0-2, 2-4, 4-8, 8-12, 
12-18, 18-24, 24-36, 36-48, 48-72, and 72-108 hours post first dose of study drug. 
• Plasma samples will be obtained at the following timepoints:  0 hours (prior to first dose), and at 
2, 6, 8, 12 (prior to second dose), 24, 36, 48, 72, and 108 hours post first dose of study drug for 
determination of ibrexafungerp in plasma concentrations. The 12-hour samples will be taken 
prior to the second dose of ibrexafungerp. 
The following plasma pharmacokinetic parameters: area under the curve (AUC), peak plasma 
concentration (Cmax), time to peak plasma concentration (Tmax), plasma clearance or apparent oral 
clearance (CL/F), apparent volume of distribution (Vd), and terminal half-life (t1/2) for ibrexafungerp 
following oral administration of the VVC dosage regimen for ibrexafungerp will be determined for 
both breast milk and plasma concentrations. 
The daily infant dosage (total drug present in milk and consumed by the infant per day) will be 
calculated: 
• 
Daily Infant Dosage (mg/day) = Σ (total drug concentration in each milk collection 
multiplied by the expressed milk volume in each milk collection) 
The Milk Plasma ratio (M/P) will be calculated. M/P = AUC0-24 milk/AUC0-24 plasma. 
The calculation of M/P should be based on AUC and on multiple time points over 24 hours and not 
just a single point in time. 
The relative infant dose (the percent of the weight-adjusted maternal dosage consumed in breast milk 
over 24 hours) will be calculated: 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 10 
 
 
• Relative Infant Dose = Infant Dosage (mg/kg/day)/Maternal Dosage (mg/kg/day) multiplied by 
100 
The PK of ibrexafungerp plasma and breastmilk will be assayed using validated LC-MSMS methods. 
Safety: 
Safety and tolerability will be assessed during the study by the collection of adverse events, vital 
signs (blood pressure, heart rate, respiratory rate, and temperature), physical examinations, and 
clinical laboratory assessments (including biochemistry, hematology, coagulation, and urinalysis). For 
each participant, adverse events will be monitored from the time of consent through poststudy visit. 
Statistical Methods: 
Pharmacokinetics: 
Individual participant plasma and breast milk concentrations, actual milk and blood sampling times, 
actual volume of milk collected per interval, actual dosing information (actual time and date of 
dosing, and actual dose taken), and PK parameters for individuals and the group will be listed in 
tabular format. Plasma ibrexafungerp concentrations measured over time will be displayed 
graphically. Plasma ibrexafungerp concentrations and PK parameters will be summarized using 
descriptive statistics. The PK parameters of ibrexafungerp will include AUC, Cmax, Tmax, CL/F, Vd, 
and t1/2. 
Breast milk concentrations and PK parameters will be summarized using descriptive statistics. For the 
PK parameters of ibrexafungerp in breastmilk: AUC for the different collection periods, Cav based on 
AUC derived from collections at different time points; total milk concentration data will be used to 
calculated Cmax, Cmin and Tmax. 
Interim Analysis: 
An interim analysis will be conducted after five subjects have completed their participation in the 
study. The analysis will involve the examination of pharmacokinetic and safety data and will 
comprise a full analysis as described in the SAP. The objective of the interim analysis is to determine 
whether the data from 5 participants is sufficient to address the objectives of the study and fulfill the 
post marketing requirement (PMR 4069-2); if not the study shall continue to recruit up to 
10 participants. 
The reporting analysis will involve descriptive statistical methods, including summaries, tabulations, 
graphs, or by-subject listings. Before initiating this analysis, the data for the study endpoints will 
undergo a thorough cleaning process, and the database will be soft-locked. 
Safety: 
All adverse events and other safety evaluations (vital signs and clinical safety laboratory tests) will be 
listed by participant and tabulated. Summary statistics and plots for safety parameters will be 
generated for the change from baseline values, as deemed clinically appropriate. Adverse events will 
be coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) and 
presented by system organ class and preferred terms. 
Statistical Power: 
There is no formal power calculation. The N is based on practical aspects of recruitment in this 
population. A sample size of up to 10 participants to complete the study is selected, with the intention 
of stopping the study at the interim analysis if the data from 5 participants are considered to be 
adequate to meet study objectives. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 11 
 
 
5. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................ I 
1.1. 
Version 4.0 Summary of Changes (13-March-2024): ..................................................2 
1.2. 
Version 3.0 Summary of Changes (26-May-2023): .....................................................3 
1.3. 
Version 2.0 Summary of Changes (04-October-2022): ................................................4 
2. 
CONTACT INFORMATION ......................................................................................5 
3. 
PROTOCOL APPROVALS .........................................................................................6 
4. 
SYNOPSIS ...................................................................................................................8 
5. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............11 
6. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................16 
7. 
INTRODUCTION ......................................................................................................19 
7.1. 
Background .................................................................................................................19 
7.2. 
Rationale for Trial .......................................................................................................20 
7.2.1. 
Benefits and Risks of Breastfeeding ...........................................................................21 
7.2.2. 
Rationale for Interim Analysis ....................................................................................21 
8. 
TRIAL OBJECTIVES AND PURPOSE ....................................................................21 
8.1. 
Primary Objective .......................................................................................................21 
8.2. 
Secondary Objectives .................................................................................................21 
9. 
INVESTIGATIONAL PLAN .....................................................................................22 
9.1. 
Overall Study Design ..................................................................................................22 
9.2. 
Number of Participants ...............................................................................................24 
9.3. 
Criteria for Study Termination ...................................................................................24 
9.4. 
Potential Risks and Discomforts .................................................................................24 
9.4.1. 
Potential Risks ............................................................................................................24 
9.4.2. 
Potential Discomforts .................................................................................................24 
10. 
SELECTION AND WITHDRAWAL OF PARTICIPANTS.....................................25 
10.1. 
Participant Selection Criteria ......................................................................................25 
10.1.1. 
Inclusion Criteria ........................................................................................................25 
10.1.2. 
Exclusion Criteria .......................................................................................................26 
10.2. 
Participant Withdrawal Criteria ..................................................................................27 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 12 
 
 
11. 
TREATMENT OF PARTICIPANTS .........................................................................28 
11.1. 
Description of Study Drug ..........................................................................................28 
11.2. 
Prior and Concomitant Medications ...........................................................................28 
11.3. 
Study Restrictions .......................................................................................................29 
11.3.1. 
Alcohol Restrictions ...................................................................................................29 
11.3.2. 
Caffeine Restrictions ..................................................................................................29 
11.3.3. 
Smoking Restrictions ..................................................................................................29 
11.3.4. 
Activity Restrictions ...................................................................................................29 
11.3.5. 
Breast Feeding ............................................................................................................29 
11.3.6. 
Contraception ..............................................................................................................29 
11.4. 
Treatment Compliance ................................................................................................30 
11.5. 
Standard Meals (in clinic) ...........................................................................................30 
11.5.1. 
Standard Meal .............................................................................................................30 
11.6. 
Randomization and Blinding ......................................................................................30 
11.7. 
Study Procedures ........................................................................................................31 
11.7.1. 
Prestudy Screening (Day -28 to Day -1) .....................................................................31 
11.7.2. 
Predose (Prior to Day 1 Morning Dosing) ..................................................................32 
11.7.3. 
Treatment Day 1 .........................................................................................................33 
11.7.4. 
Day 2 (24-hours postdose) through Day 4 ..................................................................33 
11.7.5. 
Day 5 (Post-Study) .....................................................................................................33 
12. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................36 
12.1. 
Study Drug ..................................................................................................................36 
12.2. 
Study Drug Packaging and Labeling ..........................................................................36 
12.2.1. 
Bulk Container ............................................................................................................36 
12.3. 
Study Drug Storage .....................................................................................................36 
12.4. 
Study Drug Preparation and Administration ..............................................................37 
12.5. 
Study Drug Accountability .........................................................................................37 
12.6. 
Study Drug Handling and Disposal ............................................................................37 
13. 
PHARMACOKINETIC ASSESSMENTS .................................................................38 
13.1. 
Blood Sample Collection ............................................................................................38 
13.2. 
Breast Milk Collection ................................................................................................38 
13.3. 
Sample Data ................................................................................................................38 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 13 
 
 
14. 
ASSESSMENT OF SAFETY .....................................................................................38 
14.1. 
Safety Parameters .......................................................................................................38 
14.1.1. 
Demographic/Medical History ...................................................................................38 
14.1.2. 
Vital Signs ..................................................................................................................38 
14.1.3. 
Weight and Height ......................................................................................................39 
14.1.4. 
Physical Examination and Physical Activity Questioning .........................................39 
14.1.5. 
Electrocardiogram (ECG) ...........................................................................................39 
14.1.6. 
Laboratory Assessments .............................................................................................39 
14.1.6.1. 
Hematology .................................................................................................................39 
14.1.6.2. 
Coagulation .................................................................................................................40 
14.1.6.3. 
Blood Chemistry .........................................................................................................40 
14.1.6.4. 
Urinalysis ....................................................................................................................40 
14.1.6.5. 
Alcohol and Urine Drug Screens ................................................................................40 
14.1.6.6. 
Virus Serology ............................................................................................................41 
14.1.6.7. 
Pregnancy Screen ........................................................................................................41 
14.1.6.8. 
COVID Screen ............................................................................................................41 
14.1.6.9. 
Adverse Event and Concomitant Medication Assessments ........................................41 
14.1.7. 
Blood Volume Requirements .....................................................................................41 
14.2. 
Adverse and Serious Adverse Events .........................................................................41 
14.2.1. 
Definition of Adverse Events .....................................................................................41 
14.2.1.1. 
Serious Adverse Event (SAE) ....................................................................................42 
14.2.1.2. 
Other Adverse Event (OAE) .......................................................................................42 
14.2.2. 
Unexpected Adverse Event .........................................................................................43 
14.2.3. 
AE and SAE Follow-up ..............................................................................................43 
14.2.4. 
Medical Emergencies ..................................................................................................43 
14.2.5. 
Protocol Deviations for an Adverse Event .................................................................44 
14.2.6. 
Additional Needed Clinical Laboratory Tests ............................................................44 
14.2.7. 
Relationship to Study Drug ........................................................................................44 
14.2.8. 
Recording Adverse Events .........................................................................................44 
14.2.9. 
Reporting Adverse Events ..........................................................................................45 
15. 
STATISTICS ..............................................................................................................46 
15.1. 
Analytical Plan ............................................................................................................46 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
Page 14 
 
 
15.2. 
Sample Size Determination ........................................................................................46 
15.3. 
Safety Analyses ..........................................................................................................46 
15.4. 
Pharmacokinetic Analysis ..........................................................................................46 
15.5. 
Interim Analysis ..........................................................................................................47 
16. 
STUDY COMPLETION AND TERMINATION ......................................................47 
16.1. 
Study Termination ......................................................................................................48 
17. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................48 
17.1. 
Study Monitoring ........................................................................................................48 
17.2. 
Investigator Study Files ..............................................................................................48 
17.3. 
Audits and Inspections ................................................................................................49 
17.4. 
Institutional Review Board (IRB)/ Ethics Committee (EC) .......................................49 
18. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................49 
19. 
ETHICS ......................................................................................................................50 
19.1. 
Ethics Review .............................................................................................................50 
19.2. 
Ethical Conduct of the Study ......................................................................................50 
19.3. 
Written Informed Consent ..........................................................................................50 
19.4. 
Participant Confidentiality ..........................................................................................50 
19.5. 
Financial Disclosure ...................................................................................................51 
20. 
DATA HANDLING AND RECORDKEEPING .......................................................51 
20.1. 
Inspection of Records .................................................................................................51 
20.2. 
Retention of Records ..................................................................................................51 
21. 
LIST OF REFERENCES ............................................................................................52 
APPENDIX A. TIME WINDOWS FOR SERIAL ASSESSMENTS ........................................53 
APPENDIX B. SERIOUS ADVERSE EVENT REPORTING .................................................54 
APPENDIX C. PROHIBITED MEDICATIONS .......................................................................55 
 
LIST OF TABLES 
Table 1: 
Abbreviations and Specialist Terms ...........................................................................16 
Table 2: 
Ibrexafungerp Dosing Schedule .................................................................................22 
Table 3: 
Investigational Product ...............................................................................................28 
Table 4: 
Standard Meal Definition ............................................................................................30 
Table 5: 
Schedule of Assessments ............................................................................................34 


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Table 6: 
Blood Volume Table ...................................................................................................41 
 
LIST OF FIGURES 
Figure 1: 
Study Design ...............................................................................................................23 


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6. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: 
Abbreviations and Specialist Terms 
Abbreviation or Specialist Term 
Explanation 
AE 
Adverse event 
ALT 
Alanine Aminotransferase 
aPTT 
Activated partial thromboplastin time 
AST 
Aspartate Aminotransferase 
AUC 
Area under the concentration-time curve 
AUC0-∞ 
Area under the concentration-time curve from time 0 to 
infinity 
BID 
Twice a day 
BMI 
Body Mass Index 
BP 
Blood pressure 
°C 
Degrees Celsius 
CFU 
Colony forming unit 
CI 
Confidence interval(s) 
CIOMS 
Council for International Organizations of Medical 
Sciences 
CL/F 
Apparent total clearance of the drug from plasma after 
oral administration 
Cmax 
Maximum concentration 
CPK 
Creatine phosphokinase 
CRO 
Contract Research Organization 
CT 
Compressed tablet 
CYP3A4 
Cytochrome P450 3A4 
DFC 
Dry filled capsule 
ECG 
Electrocardiogram 
ECI 
Event of clinical interest 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
GGT 
Gamma-glutamyl transferase 
GI 
Gastrointestinal 
HCT 
Hematocrit 
HgB 
Hemoglobin 
HR 
Heart rate 


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Abbreviation or Specialist Term 
Explanation 
H or hr 
Hour 
β-hCG 
Human Chorionic Gonadotropin 
Σ 
Total drug concentration in each milk collection 
multiplied by the expressed milk volume in each milk 
collection 
IB 
Investigator’s Brochure 
IC 
Inhibitory concentration 
ICH 
International Conference on Harmonization 
INR 
International Normalized Ratio 
IPA 
Invasive pulmonary aspergillosis 
IRB/EC 
Institutional Review Board/Ethics Committee 
Kcal 
Kilocalories 
kg 
Kilograms 
KOH 
Potassium Hydroxide 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mL 
Milliliter 
M/P 
Milk plasma ratio 
OAE 
Other Adverse Event 
OCP 
Oral contraceptive pills 
OTC 
Over-the-counter 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
PMR 
Post Marketing Requirement 
PT 
Prothrombin time 
Q12H 
Every 12 hours 
RBC 
Red blood cell 
REB 
Research Ethics Board 
RR 
Respiratory rate 
rVVC 
Recurrent vulvovaginal candidiasis 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SOC 
Standard of Care; System Organ Class 
SOP 
Standard Operating Procedure 
SUSAR 
Suspected, Unexpected Serious Adverse Reaction 
T 
Temperature 


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Abbreviation or Specialist Term 
Explanation 
t½ 
Terminal half-life 
TEAE 
Treatment Emergent Adverse Event 
TG 
Triglycerides 
TLF 
Tables, Listings, and Figures 
Tmax 
Time to maximum concentration 
WBC 
White blood cell 
Vd 
Apparent volume of distribution 
VVC 
Vulvovaginal candidiasis 
 


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7. 
INTRODUCTION 
7.1. 
Background 
Vulvovaginal Candidiasis 
Vulvovaginal candidiasis (VVC) is a common fungal infection caused by Candida spp. and is a 
significant morbidity condition in women from all social classes. 
Information on the incidence of VVC is incomplete, since the disease is not a reportable entity 
and data collection is hampered by inaccuracies of diagnosis and the use of non-representative 
study populations (Sobel, 2007). VVC affects 70%–75% of women at least once during their 
lives, most frequently young women of childbearing age. Approximately 40%–50% of women 
will experience a recurrence (Hurley and De Louvois, 1979) and 5% to 8% of adult women have 
a recurrent vulvovaginal candidiasis (Foxman et al, 1998). 
Current treatments for VVC include topical antifungals and the use of prescription oral 
antifungals such a single dose of fluconazole. In two vaginal candidiasis studies conducted with 
fluconazole, the therapeutic cure rate, defined as the resolution of signs and symptoms of vaginal 
candidiasis along with negative potassium hydroxide (KOH) examination and negative culture 
for Candida, was achieved by 55% of participants receiving single doses of fluconazole 150 mg. 
The therapeutic cure rate is reduced to 40% in participants with a history of recurrent vaginitis 
(Pfizer, 2014 and Sobel, 2006). Although a single dose of fluconazole is able to provide an 
acceptable therapeutic outcome for more than half of the treated individuals, the emergence of 
fluconazole resistance among C. albicans isolates and the frequency of cases caused by 
C. glabrata, a strain naturally less susceptible to fluconazole, signals the need for new 
therapeutic approaches. 
Additionally, recurrence of VVC after fluconazole therapy is not uncommon and these 
exacerbations often involve the same microorganism identified in the initial episode, suggesting 
that a small number of C. albicans remain as a reservoir in the vagina after completion of azole 
therapy, becoming the source of subsequent exacerbations. This may be explained by the fact 
that azoles are fungistatic, which means that they slow the growth of, but do not kill, the fungus 
and azoles are not active against certain species of Candida that cause VVC. 
New curative approaches are needed, particularly involving agents with fungicidal activity (ie, 
that are able to kill the fungus) and activity against fluconazole-resistant strains, so that the 
causative yeasts can be eradicated. A new therapeutic approach with these characteristics would 
be expected to result in improved short-term and potentially long-term outcomes for this 
condition. 
Ibrexafungerp is the first of the triterpenoid class of ß-1,3-D glucan synthase inhibitors. It is a 
semi-synthetic derivative of the natural product enfumafungin with in vitro and in vivo activity 
against Candida species. 
It has the same molecular target as the echinocandins but is structurally distinct and may interact 
differently at the target due to its activity against echinocandin-resistant strains. 
Ibrexafungerp has fungicidal in vitro activity against Candida species similar to that observed 
with the echinocandins. By way of comparison, the azoles are fungistatic, with colony forming 
unit (CFU) counts that parallel the growth control arm. 


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In June 2021 the US Food and Drug Administration (FDA) approved Ibrexafungerp 
(Brexafemme Label, 2021) for treatment of Vulvovaginal candidiasis. 
Adult Pharmacokinetics Summary:  After oral, single-dose administration, peak plasma 
ibrexafungerp concentrations occur within approximately 4 to 6 hours post-dose. Plasma 
concentrations declined from Cmax in an approximately monophasic decline, with a harmonic 
mean terminal half-life (t½) of ⁓20 hours. The mean AUC0-∞ and Cmax appeared, in general, to be 
dose proportional for doses from 10 mg to 1600 mg. Plasma exposures of ibrexafungerp were not 
altered in participants who were older than 65 years compared to younger participants or in 
female compared to male participants after single oral dose administration. 
Ibrexafungerp elimination is primarily hepatic metabolism; and approximately 1 to 2% of the 
total dose is excreted by the kidney following administration of a single IV dose. 
Approximately 1625 participants received at least one dose of ibrexafungerp in completed and 
ongoing clinical studies: Phase 1 studies in healthy participants (n=468), in patients with liver 
impairment (n=16) and in patients with vulvovaginal candidiasis (VVC) (n=16) and Phase 2 and 
3 studies (n=1125) in patients with either invasive / severe mucocutaneous fungal infections or 
VVC. Ongoing clinical studies include one Phase 1 study evaluating IV liposomal formulation of 
ibrexafungerp in healthy participants, one Phase 1 study in healthy participants and VVC 
patients, one Phase 2 study in patients with invasive pulmonary aspergillosis (IPA), one Phase 3 
study in patients with fungal diseases refractory or intolerant to standard-of-care (SOC) 
treatment, and one Phase 3 study in patients with documented C. auris infection. 
Ibrexafungerp was generally well tolerated following single oral doses of up to 1600 mg and 
multiple oral doses of up to 800 mg for 28 consecutive days administered as dry filled capsules 
(DFCs), phosphate compressed tablets (CTs) or citrate CTs in Phase 1 studies. 
Most of the adverse events (AEs) considered related to oral ibrexafungerp across studies were of 
gastrointestinal (GI) nature and included, but were not limited to, diarrhea, abdominal pain, 
nausea, and vomiting. Headache was also a frequently reported treatment-related AE with oral 
dosing. Most treatment-related AEs reported with oral ibrexafungerp were mild to moderate in 
severity. Despite gastric mucosal degeneration findings in rat and dog studies, serum gastrin 
levels and gastric biopsies have not shown clinically significant gastrin level changes or 
histological evidence of mucosal degeneration in healthy volunteers. 
Refer to the Investigator’s Brochure (IB) and the Brexafemme® (ibrexafungerp) label 
(Brexafemme Label, 2021) for additional information. 
7.2. 
Rationale for Trial 
The primary purpose of this study is to determine whether ibrexafungerp is excreted in breast 
milk of lactating women, and if so, to characterize PK in breast milk and plasma; calculate the 
potential infant exposure if lactating women are treated with ibrexafungerp; and characterize the 
safety and tolerability in lactating women. Based on 24-hour half-life, it is expected that 
approximately 15% of ibrexafungerp remains after 72 hours, so the collection period of 
0 through 108 hours is considered sufficient to characterize the PK parameters. 
Vulvovaginal candidiasis (VVC) is a common genital infection in women caused by 
Candida spp., primarily C. albicans and C. glabrata. Several studies have reported that 75% of 


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women experience at least one episode of VVC during their lifetime and 5 to 10% experience 
recurrent VVC (rVVC) (Sobel, 2007). 
Based on FDA Lactation Study Guidance (FDA Guidance, 2019), this drug has expected use in 
women of reproductive age similar to the marketed drugs that are currently commonly used for 
the indication of VVC in reproductive aged women. 
Consequently, evaluation of products for treatment of lactating women with VVC is of 
importance. 
7.2.1. 
Benefits and Risks of Breastfeeding 
The benefits of breastfeeding compared to the risks of interruption of breastfeeding, including 
the potential for changes in milk supply and difficulty re-establishing breastfeeding after the 
study will be discussed with the participants. 
7.2.2. 
Rationale for Interim Analysis 
Given the nature of the study population and practical aspects of conducting a study in lactating 
women, a decision was taken to include an interim analysis to determine whether the data from 
5 participants is sufficient to address the objectives of the study and fulfill the post marketing 
requirement (PMR 4069-2); if not the study shall continue to recruit up to 10 participants. 
An interim study analysis with full analysis of the PK as described in Section 15.5, and safety 
data collected from these first 5 subjects will be carried out. 
The reporting analysis will involve descriptive statistical methods, including summaries, 
tabulations, graphs, or by-subject listings. Before initiating this analysis, the data for the study 
endpoints will undergo a thorough cleaning process, and the database will be soft-locked.  
8. 
TRIAL OBJECTIVES AND PURPOSE 
8.1. 
Primary Objective 
• To determine whether ibrexafungerp is excreted in breast milk and if so, to 
characterize ibrexafungerp pharmacokinetics (PK) in the breast milk and plasma of 
lactating women. 
8.2. 
Secondary Objectives 
• To calculate the potential infant exposure to ibrexafungerp if lactating women are 
treated with ibrexafungerp. 
• To characterize the safety and tolerability of ibrexafungerp in lactating women. 


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9. 
INVESTIGATIONAL PLAN 
9.1. 
Overall Study Design 
Ibrexafungerp is approved in the United States as a single day, two-dose therapy for women with 
vulvovaginal candidiasis. This is a Phase 1study designed to determine whether this dose of 
ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast 
milk and plasma of lactating women. Up to 10 healthy lactating females who are at least 10 days 
postpartum with a full milk supply established and are between the ages of 18 and 50 years at the 
time of screening are planned to be enrolled. (Enough participants will be enrolled to complete 
up to 10 evaluable participants.) 
Participants will receive a single day of twice daily (BID) dosing given 12 hours apart (Q12H) 
oral 300-mg ibrexafungerp. Participants will receive both doses on site. 
Participants will be admitted to the clinic prior to dosing on Day -1, and may be discharged on 
Day 5, after the 108-hour procedures are completed, at the discretion of the investigator. The 
duration of study participation from pre-study through post-study safety monitoring will be 
approximately 4 to 5 weeks for participants. 
Safety will be monitored with clinical and laboratory evaluations. Breast milk and plasma 
samples will be obtained at selected time points pre-dose and post-dose for determination of 
ibrexafungerp concentrations. 
Participants who discontinue or are discontinued may be replaced at the discretion of the 
investigator and Sponsor to ensure that up to 10 evaluable participants complete the study. An 
interim analysis will be performed after 5 subjects have completed the study. 
Participants will take ibrexafungerp on Day 1 Q12H with food following the schedule below in 
Table 2. 
Table 2: 
Ibrexafungerp Dosing Schedule 
Product, Dose, and Timing 
Study Day 
Ibrexafungerp 300-mg BID on Day 1  
1 
A complete schedule of assessments is provided in Table 5. A schematic of the study design is 
provided in Figure 1. 


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Figure 1: 
Study Design 
 
Screening 
Day 1
Ibrexafungerp 300-mg AM dose
Ibrexafungerp 300-mg PM dose
Days 2 through 5 (Post-study)
Discharge after the 108-hour procedures


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9.2. 
Number of Participants 
Up to 10 healthy lactating females who are at least 10 days postpartum with a full milk supply 
established and are between the ages of 18 and 50 years, inclusive, at the time of screening. 
Enough participants will be enrolled to complete up to 10 evaluable participants. 
9.3. 
Criteria for Study Termination 
The principal investigator, the sponsor, the appropriate regulatory authorities, and the ethics 
committee (EC) each reserve the right to terminate the study in the interest of participants’ safety 
and welfare. The sponsor reserves the right to terminate the study at any time for administrative 
reasons. 
9.4. 
Potential Risks and Discomforts 
9.4.1. 
Potential Risks 
Ibrexafungerp at the one day of 2 X 150-mg dose may cause some side effects. Participants will 
be notified that they may experience none, some, or all of the side effects listed below because 
medicine can affect individual people in different ways. In addition, the study medication may 
involve risks that are currently unknown. Participants will be asked to tell the study staff 
immediately if they experience any side effects while participating in this study, however minor. 
Potentials risks of ibrexafungerp: 
• gastrointestinal (diarrhea, abdominal pain, nausea, and vomiting); 
• elevation in liver enzymes (AST/ALT); 
• hypersensitivity reactions; 
The risks of interruption of breastfeeding: 
• potential for changes in milk supply  
• difficulty re-establishing breastfeeding after the study completion 
9.4.2. 
Potential Discomforts 
Participants may feel discomfort during some of these tests or may experience some 
inconveniences. Some may also have risks, which may include: 
• Blood samples: drawing blood from your arm may cause pain, bruising, 
lightheadedness, and rarely infection 
• Electrocardiogram (ECG): ECG patches may cause a skin reaction such as redness or 
itching 
• Breast Pump Usage (Medela, 2022): Pumping breastmilk shouldn’t hurt, but 
participants may feel discomfort while expressing breastmilk, or get blisters or 
chafing on their nipples or breasts. 
− Note: a lactation specialist will be available to answer any participant questions or 
concerns. 


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10. 
SELECTION AND WITHDRAWAL OF PARTICIPANTS 
10.1. 
Participant Selection Criteria 
10.1.1. 
Inclusion Criteria 
A female will be included in the study if she meets the following inclusion criteria if the 
participant: 
1. is a healthy lactating woman aged 18 to 50 years, inclusive, at Screening. 
2. is at least 10-days postpartum after uncomplicated delivery with a full milk supply 
established. (There is no specific length of time postpartum). 
3. is actively breastfeeding or expressing breast milk. 
4. is willing to temporarily discontinue breast feeding their infant before the Day 1 morning 
dose through to 108 hours after the first dose (approximately 4.5 days) AND has the 
ability to pump breast milk and to provide a reserve for infant feeding, with acceptance of 
bottle feeding, prior to the study. 
OR 
has decided to discontinue breastfeeding permanently but has not yet started weaning 
their infant with acceptance of bottle feeding for the infant. Participants must have an 
adequate milk supply (if pumping at least 3 to 4 times a day) as milk composition 
changes during the weaning process. 
Note: Care should be taken to ensure that participants have not discontinued 
breastfeeding an infant in order to participate in the study. 
Note: Alternative infant nutrition (previously stored breastmilk or infant formula) should 
be available for feeding the infant from study Day 1 through 96 hours after the second 
dose (108 hours after the first dose). 
Note: A lactation specialist will be available for participant support during the study. 
5. is willing to fully express breast milk from both breasts during the duration of the milk 
collection portion of the study. Participants must be able to express milk from each breast 
at each pumping session using an electric breast pump. 
6. has a Body Mass Index (BMI) ≤34 kg/m2 at the screening visit. BMI is calculated by 
taking the participant’s weight in kg and dividing by the participant’s height in meters, 
squared. 
7. is judged to be in good health based on medical history, physical examination, vital sign 
measurements, and laboratory safety tests (all within laboratory normal ranges or changes 
outside the normal range judged to be clinically non-significant by the investigator) 
performed at the screening visit and prior to administration of the initial dose of study 
drug. 
8. has no clinically significant abnormality on electrocardiogram (ECG) performed at the 
screening visit. 


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9. has been a non-smoker (including vaping) or a light smoker (less than 10 cigarettes per 
day) for at least 6 months. 
10. understands the study procedures and agrees to participate in the study by giving written 
informed consent. 
11. is willing to comply with the study restrictions and participate for the full length of the 
study for a complete summary of study restrictions see Section 11.3. 
12. is not pregnant and highly unlikely to become pregnant. 
a. A female participant who is of reproductive potential agrees to remain abstinent or 
use (or have their partner use) 2 acceptable methods of contraception starting from 
the time of consent through the post-study visit. Acceptable methods of birth control 
for female participants are intrauterine device, diaphragm with spermicide, 
contraceptive sponge, and condom. For female participants, oral contraceptive pills 
(OCP) are not to be used as contraception as the effect of ibrexafungerp on the 
efficacy of OCP has not yet been established. 
b. Women of childbearing potential must have a negative serum pregnancy test 
(β human chorionic gonadotropin [β-hCG]) prior to enrolment (performed by the 
site’s local laboratory). 
10.1.2. 
Exclusion Criteria 
A female will be excluded from participation in the study if they meet any of the following 
exclusion criteria if the participant: 
1. is pregnant or unwilling or unable to comply with the lifestyle guidelines presented in the 
protocol during the study period and through the Post-Study visit. 
2. has evidence or history of clinically significant hematological, renal, endocrine, 
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post-natal 
depression), neurologic, allergic disease (including drug allergies, but excluding 
untreated asymptomatic, seasonal allergies at time of dosing), or a history of neoplastic 
disease or any active cancer. 
3. is mentally or legally incapacitated. 
4. has a history of any illness or clinical findings that, in the opinion of the study 
investigator, might confound the results of the study or poses an additional risk to the 
participant or infant by participation in the study. 
5. anticipates the use of prescription or non-prescription drugs that are strong CYP3A4 
inducers, including vitamins, herbal and dietary supplements (including St. John's Wort) 
within 7 days of study drug administration (or 14 days if the drug is a potential enzyme 
inducer), see the list of excluded concomitant medication examples in Appendix C. 
6. is unable to refrain from consumption of grapefruit juice, grapefruits, grapefruit products, 
star fruit, Seville and blood oranges, apple and mulberry juice as well as vegetables from 
the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, 
Brussels sprouts, and mustard), charbroiled meats, and fenugreek beginning 


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approximately 7 days prior to administration of the initial dose of study drug and 
throughout the participant’s stay in the clinic. 
7. consumes significant amounts of alcohol, defined as greater than 2 glasses of alcoholic 
beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine 
[125 mL/4 ounces] or distilled spirits [25 mL/1 ounce]) per day. Participant is unable to 
refrain from all alcohol consumption within one week prior to study dosing throughout 
the study until the final study visit. 
8. consumes excessive amounts of caffeine for one month prior to study drug 
administration, defined as greater than 6 servings (1 serving is approximately equivalent 
to 120 mg of caffeine) of coffee, tea, cola or other caffeinated beverages per day. 
9. has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or 
participated in another investigational study within 30 days or 5½ half-lives of the 
investigational product prior to the screening. The 30-day window will be derived from 
the date of the last study procedure (ie, poststudy, AE follow-up, etc.) in the previous 
study to the screening visit of the current study. 
10. has a history of significant multiple and/or severe allergies [including latex allergy, but 
with exception of seasonal rhinitis (hay fever)] or has had an anaphylactic reaction or 
significant intolerability to prescription or non-prescription drugs or food. 
11. has a known hypersensitivity to ibrexafungerp. 
12. is currently a user including illicit drugs or has a history of drug (including alcohol) abuse 
within approximately 1 year. 
13. is unable to abstain from strenuous exercise from the screening visit until administration 
of the initial dose of study drug, throughout the study until the poststudy visit. 
10.2. 
Participant Withdrawal Criteria 
A participant may be prematurely withdrawn from the study if they develop a toxicity or 
concurrent illness that, in the investigator’s judgment, precludes further participation in the study 
for the following reasons: 
• Occurrence of an AE that, in the judgment of the investigator, warrants withdrawal of 
the participant from the study drug; 
A participant may also be permanently withdrawn from the study for any of the following 
reasons: 
• Pregnancy 
• Non-compliance (not completing all required assessments at required times, or 
missing scheduled visits) or protocol violation; 
• Withdrawal of consent and refusal to participate further in the study; 
• Investigator or Sponsor decision that withdrawal is in the participant’s best interest; 
• Termination of the study by the Sponsor or health authority; 


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• Lost to follow-up; 
• Administrative decision of sponsor. 
If a participant is to be labeled as lost to follow-up the site is required to make efforts to contact 
the participant following a missed visit. 
All participants who withdraw from the study will be followed up and data collection will 
continue for all available information collected per protocol. 
Participants who discontinue or are discontinued may be replaced at the discretion of the 
investigator and Sponsor to ensure that up to 10 evaluable participants complete the study. 
11. 
TREATMENT OF PARTICIPANTS 
11.1. 
Description of Study Drug 
The Sponsor will provide the study site with adequate clinical supplies including: 150-mg 
ibrexafungerp tablets of the citrate salt formulation (Table 3). 
Table 3: 
Investigational Product 
 
Investigational Product 
Product Name: 
Ibrexafungerp tablets (as citrate salt) 
Dosage Form: 
150-mg ibrexafungerp tablets (as citrate salt) 
Unit Dose: 
2 X 150-mg tablets for the 300-mg dose  
Route of Administration: 
Oral 
Physical Description: 
150-mg compressed tablets 
Manufacturer: 
SCYNEXIS, Inc. 
11.2. 
Prior and Concomitant Medications 
All medications (including prescription and over-the-counter (OTC) medications, supplements, 
and herbal products) taken within 14 days before dosing (Day 1) and through post-study 
assessments will be recorded on the electronic case report form (eCRF). The identity of the 
therapy, the dose, route, and regimen, the dates started and stopped (or continuing), and the 
reason for use must be recorded on an eCRF. If a participant is not able to discontinue all prior 
medications within 14 days or 5 half-lives prior to administration of the initial dose of study 
medication, and they have been approved by the SCYNEXIS medical monitor, these medications 
will be noted on the prior medication forms. 
Appendix C is a list of prohibited medications for this study. Sunflower lecithin, malta goya, and 
other herbal fenugreek-free products may be utilized to increase milk production and may be 
allowed at the discretion of the Investigator after consultation and approval with the SCYNEXIS, 
Inc. clinical monitor. These supplements and other medications if used must be recorded on the 
eCRF. Acetaminophen may be used for minor ailments at the discretion of the investigator 
without prior consultation with the SCYNEXIS, Inc. clinical monitor. Additionally, medication 


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13 March 2024 
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(other than those in Appendix C) that a participant cannot stop may be allowed at the discretion 
of the Investigator after consultation and approval with the SCYNEXIS, Inc. clinical monitor. 
Best medical judgement by the investigator as to how to treat AEs is primary, however if time 
permits the investigator should consult with the medical monitor when concomitant medications 
are being considered. The use of any concomitant medication must relate to an AE or the 
participant's medical history and must be recorded on eCRF as described above. 
11.3. 
Study Restrictions 
11.3.1. 
Alcohol Restrictions 
Participants will refrain from all consumption of alcohol within 1 week prior to dosing, 
throughout the study, and through the final study visit. 
11.3.2. 
Caffeine Restrictions 
Participants will refrain from the consumption of caffeine while in the clinical research unit. 
11.3.3. 
Smoking Restrictions 
Only non-smokers or light smokers (participants smoking less than 10 cigarettes/day) are 
permitted to participate. Participants will not be allowed to smoke during the admission period. 
11.3.4. 
Activity Restrictions 
Participants will avoid all unusual or strenuous physical activity (ie, running/bicycling races, 
weightlifting, etc.) from the prestudy (screening) visit, while in the clinical research unit, until 
the poststudy visit. Participants will be questioned as to the physical activity at prestudy. 
Participants will be resting in an undisturbed environment in the supine or semi-recumbent 
position for at least 10 minutes prior to vital signs or ECG collection. 
11.3.5. 
Breast Feeding 
Participants must refrain from all infant breast feeding from prior to dosing on study Day 1 
through Day 5 (96 hours after the second dose). Alternative infant nutrition (previously stored 
breastmilk or infant formula) will be used for feeding the infant during this time period, with 
acceptance of bottle feeding prior to study start. If a participant discontinues from the trial early 
for any reason, she must not breast feed her infant until after Day 5 or 96 hours after the second 
dose of study drug. 
11.3.6. 
Contraception 
Female participants who are of reproductive potential must not be pregnant or planning to 
become pregnant. If participants are of reproductive potential they must agree to; 1.) remain 
abstinent (true abstinence is defined as abstaining from heterosexual sex and the preferred and 
usual lifestyle of the participant or 2.) use (or have their partner use) 2 acceptable methods of 
contraception starting from the time of consent through 96 hours after the completion of study 
therapy. 


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Acceptable methods of birth control are non-hormonal intrauterine device, diaphragm with, 
contraceptive sponge, condom, and vasectomy. Oral contraceptive pills are not to be relied upon 
as an acceptable method of contraception since the effect of ibrexafungerp on the efficacy of oral 
contraceptive pills has not yet been established. 
NOTE: Women of childbearing potential must have a negative pregnancy test (β human 
chorionic gonadotropin [β-hCG]) at Screening visit and at admission to the clinic. 
11.4. 
Treatment Compliance 
All doses of study drug will be administered in the clinical unit under direct observation of clinic 
personnel and recorded in the eCRF. Clinic personnel will confirm that the participant has 
swallowed the entire dose of study drug by mouth check. If a participant does not swallow the 
entire dose of study drug, the amount taken and the reason for the incomplete or missed dose will 
be recorded. 
The date and exact time of study drug dosing will be recorded on the appropriate page of the 
eCRF. If a participant does not receive study drug, the reason for the missed dose will be 
recorded. 
11.5. 
Standard Meals (in clinic) 
11.5.1. 
Standard Meal 
Participants will start to consume a standard meal approximately 30 minutes prior to and finish 
prior to the administration of the ibrexafungerp dose. The clinical research unit will determine 
the actual content of the standard meals, the meals should fit into the standard meal definition 
provided below in Table 4. All participants are expected to consume the same meal with regards 
to kcal and fat content prior to the AM and PM doses. 
Table 4: 
Standard Meal Definition 
Meal Type 
Total calories 
Fat 
Kcal 
Grams 
Percent 
Standard 
~600 - 800 
~132 – 420 
~16 - 47 
~27 - 42 
Other Standardized Meals and Restrictions 
While in the research unit, a standardized lunch will be provided at 4 hours and a snack at 
8 hours post AM dose, another snack will be offered at 14 hours post AM dose. The caloric 
content and composition of meals and snacks will be the same for all participants while in the 
clinical research unit. 
11.6. 
Randomization and Blinding 
This is an open-label study. Each participant will be assigned a participant’s study number (in 
numerical order as they are enrolled) prior to dosing. The participant’s study number will be used 
to identify the participant for all procedures and in eCRF. A single participant cannot be assigned 
more than 1 participant study number. 


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Clinical Protocol Number SCY-078-121 
 
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11.7. 
Study Procedures 
The following sections provide a description of the individual study procedures to be performed 
during the conduct of the study. A detailed schedule of all study procedures is presented in the 
Schedule of Assessments Table 5. See Appendix A for time windows for vital signs and PK 
sampling. 
Study procedures should be completed as close to the prescribed/scheduled time as possible. 
Procedures will be performed in the following priority of proximity (below) with regard to the 
prescribed time. For this study the blood samples for ibrexafungerp are the critical parameter and 
needs to be collected as close to the exact time point as possible. 
• Breast milk sample collection for ibrexafungerp 
• Plasma sample collection for ibrexafungerp 
• Laboratory safety tests 
• Vital signs 
• Physical examinations, (if appropriate) 
• Standard Meals 
The order of priority can be changed during the study with joint agreement of the investigator 
and SCYNEXIS, Inc. 
Any nonscheduled procedures required for urgent evaluation of safety concerns take precedence 
over all routine scheduled procedures. 
11.7.1. 
Prestudy Screening (Day -28 to Day -1) 
Screening and Day -1 procedures can be completed together the same day depending on when 
the participant is screened and able to be treated. Prestudy screening will occur within 
approximately 4 weeks prior to administration of the initial dose of study medication. Potential 
participants will be evaluated to determine that they fulfill the entry requirements as set forth in 
the inclusion and exclusion criteria. The investigator will discuss with each participant the nature 
of the study, its requirements, and its restrictions. 
Prestudy screening will include the following procedures: 
• Provision of written informed consent 
• Adverse event surveillance from the time informed consent is obtained 
• Review of inclusion/exclusion criteria 
• Demographics information 
• Medical history for the prior 1 year (including pregnancy, postpartum, and lactation 
history) 
• Prior Medication review 
• Physical examination, including body weight and height 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
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• Vital signs (HR/BP/RR/Temp) 
• 12-lead ECG 
• Laboratory safety tests 
• HIV/Hepatitis Screen 
• Pregnancy test (serum) 
• COVID, Alcohol and urine drug screen (site standard) 
For details on the procedures, please refer to the Schedule of Assessments (Table 5). 
11.7.2. 
Predose (Prior to Day 1 Morning Dosing) 
Predose is considered up to 12 hours prior to dosing (Day 1, time 0), therefore exams and tests to 
be done “predose” can be completed up to 12 hours prior to dosing (time 0). Predose safety labs 
and serum pregnancy test can be obtained up to 24-48 hours predose. 
Prior to treatment, the clinical and laboratory safety parameter values will be reviewed by the 
Investigator and discussed with the Sponsor if parameters are outside the normal range and 
considered clinically significant. 
Safety laboratory results should be known and reviewed prior to Day 1 dose. Participants shall 
report to the clinical research unit predose. The following procedures will be performed predose 
Day 1: 
• Admission to Clinic (for participant, and infant if that is the participant’s choice). 
Infant admission is not mandatory, but the site will provide this option. 
• Review of inclusion/ exclusion criteria 
• Adverse event surveillance 
• Concomitant medication review 
• Physical examination 
• Laboratory safety tests (only hematology, AST, ALT, and bilirubin will be assessed) 
• Vital signs (HR/BP/RR/Temp) 
• Pregnancy test (serum), if screening was more than 24-48 hours prior to Day 1 dosing 
• COVID, Alcohol and urine drug screen (site standard), if screening was more than 
12 hours prior to Day 1 dosing 
• Standard meals for participants (if appropriate after admission) 
• Infant feeding (previously stored breastmilk or infant formula) should be available for 
feeding the infant while housed with the participant in the clinical research unit. 
• Enrollment, participant number assignment (after all predose procedures are 
completed) 
For details on the procedures, please refer to the Schedule of Assessments (Table 5). 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
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11.7.3. 
Treatment Day 1 
Day 1, time 0 is the Day 1 AM dosage administration. The following procedures will be 
performed as noted in Table 5: 
• A standard meal with start to be consumed 30 minutes prior to the administration of 
study medication (at -30 minutes and 11.5 hours). Standard meals throughout the rest 
of the day will be provided for the participant. 
• Infant feeding (previously stored breastmilk or infant formula) should be available for 
feeding the infant while housed with the participant in the clinical research unit. 
• Ibrexafungerp 300-mg will be administered orally, at zero hour and at 12 hours, while 
the participant is in a semi-supine position with 240 mL of room temperature water. 
A mouth check will be performed to ensure dosing compliance. 
• Adverse event surveillance 
• Concomitant medication surveillance 
• Vital signs (HR/BP) 
• Breast milk sample collections for ibrexafungerp 
• Plasma sample collections for ibrexafungerp 
11.7.4. 
Day 2 (24-hours postdose) through Day 4 
• Standard meals will be provided for the participant. 
• Infant feeding (previously stored breastmilk or infant formula) should be available for 
feeding the infant while housed with the participant in the clinical research unit. 
• Adverse event surveillance 
• Concomitant medication surveillance 
• Breast milk sample collections for ibrexafungerp 
• Plasma sample collections for ibrexafungerp 
11.7.5. 
Day 5 (Post-Study) 
Prior to the Day 5 discharge from the clinic the following post-study procedures will be 
performed as noted in Table 5: 
• Standard meals will be provided for the participant. 
• Adverse event surveillance 
• Concomitant medication surveillance 
• Physical examination, including body weight 
• Vital signs (HR/BP/RR/Temperature) 
• Laboratory safety tests (Only hematology and clinical chemistry [coagulation not 
required]) 
• Pregnancy test (serum) 


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US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
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Table 5: 
Schedule of Assessments 
Study Procedures 
Screeninga 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Post-study 
Predoseb 
0 hr 
8 hr 
12 hr 
24 hr 
36 hr 
48 hr 
72 hr 
108 hr 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
 
 
Physical Examc 
X 
X 
 
 
 
 
 
 
 
X 
12-Lead ECGc 
X 
 
 
 
 
 
 
 
 
 
Enrollment 
 
X 
 
 
 
 
 
 
 
 
Demographics and Medical 
History prior 1 yr (including 
pregnancy, postpartum, and 
lactation history) 
X 
 
 
 
 
 
 
 
 
 
Height and Weightd 
X 
 
 
 
 
 
 
 
 
X 
Vital Signs (HR, BP)c 
X 
X 
 
X 
 
X 
 
 
 
X 
Vital Signs (RR, Temperature) 
X 
X 
 
 
 
 
 
 
 
X 
Safety laboratory testinge 
X 
X 
 
 
 
 
 
 
 
X 
HIV/Hepatitis Screen 
X 
 
 
 
 
 
 
 
 
 
COVID, Alcohol, and Urine 
drug screen (standard at site)f 
X 
X 
 
 
 
 
 
 
 
 
Pregnancy Tests (serum) 
X 
Xj 
 
 
 
 
 
 
 
X 
Standard Meals 
 
X-----------------------------------------------------------------------------------------------------------------X 
Study Drug Administrationg 
 
 
X 
 
X 
 
 
 
 
 
Blood Samples for 
Ibrexafungerp Concentrationh 
 
 
X-------------------------------------------------------------------------------------------X 
Breast Milk Samples for 
Ibrexafungerp Concentrationi 
 
 
X-------------------------------------------------------------------------------------------X 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
 
13 March 2024 
CONFIDENTIAL 
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Table 5: 
Schedule of Assessments (Continued) 
Study Procedures 
Screeninga 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Poststudy 
Predoseb 
0 hr 
8 hr 
12 hr 
24 hr 
36 hr 
48 hr 
72 hr 
108 hr 
Admission to Clinic and 
Discharge from Clinick 
 
X 
 
 
 
 
 
 
 
X 
Adverse Event Monitoring 
X----------------------------------------------------------------------------------------------------------------------------------X 
Prior/Concomitant Medication 
X----------------------------------------------------------------------------------------------------------------------------------X 
Abbreviations: BP = blood pressure; HR = heart rate; RR = respiratory rate, PK = pharmacokinetic, ECG = electrocardiogram, and HIV = human 
immunodeficiency virus 
a Pre-study screening to determine eligibility may be performed within 4 weeks prior to dosing with study medication. 
b The Day 1 predose examinations and assessments may be performed up to 12 hours predose. 
c During physical examination at screening and predose participants will also be asked about physical activity. Prior to ECG the participants must be in a 
semi-recumbent position for at least 10 minutes prior to having heart rate, blood pressure, and ECG performed. 
d Height documented at screening only. 
e Participants will not be required to fast prior to collecting blood and urine for laboratory safety tests. At screening a full set of laboratory tests (hematology, 
coagulation, chemistry, and urinalysis) will be assessed; at pre-dose only hematology, AST, ALT, and bilirubin will be assessed; and at poststudy only 
hematology and clinical chemistry will be assessed (coagulation will not be required). 
f Urine drug and alcohol screening will be done at screening, within 12 hours before the first dose, and upon admission to the clinic. COVID-19 testing will be 
done per site requirements. 
g Ibrexafungerp 300-mg will be administered BID Q12H on Day 1 while the participant is in a semi-supine position with 240 mL of room temperature water. 
h Plasma samples will be obtained at the following timepoints:  0 hours (prior to first dose), and at 2, 6, 8, 12, 24, 36, 48, 72 and 108 hours post first dose of study 
drug for determination of ibrexafungerp in plasma concentrations. The 12-hour samples will be taken prior to the second dose of ibrexafungerp. 
i Breast Milk:  complete expression of milk from both breasts (using a standard electric breast pump) will be obtained at the following timepoint and intervals: 
pre-dose, 0-2, 2-4, 4-8, 8-12, 12-18, 18-24, 24-36, 36-48, 48-72, and 72-108 hours post first dose of study drug. 
j Pregnancy test to be repeated if screening was more than 24 hours prior to Day 1 dosing. 
k Admission to the clinic will be prior to dosing on Day 1 (for participant, and infant if that is the participant’s choice). Infant admission is not mandatory, but the 
site will provide this option. The stay in the clinic will be through the Day 5, 108-hour, post-study procedures are complete. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
Page 36 
12. 
STUDY DRUG MATERIALS AND MANAGEMENT 
12.1. 
Study Drug 
Ibrexafungerp (SCY-078) citrate salt drug product will be supplied as 150-mg compressed 
tablets containing 150 mg of ibrexafungerp active ingredient on a free base basis. The tablet blend 
also contains calcium phosphate, silicified microcrystalline cellulose, croscarmellose sodium, 
magnesium stearate (non-bovine), povidone, Poloxamer 407, butylated hydroxyanisole. 
mannitol, crospovidone, and colloidal silicon dioxide. 
The investigator shall take responsibility for and shall take all steps to maintain appropriate records 
and ensure appropriate supply, handling, storage, distribution, and usage of these materials in 
accordance with the protocol and any applicable laws and regulations. 
The Investigational products used in the study will be supplied in sufficient quantities for 
participants and any replacement participants. The investigational supplies of ibrexafungerp citrate 
salt tablets will be provided by the Sponsor, the tablets will be provided as 150-mg ibrexafungerp 
tablets. 
The following drug supplies will be provided: 
Product 
Potency: 
Ibrexafungerp (SCY-078) Citrate Salt Tablets 
Ibrexafungerp 150-mg (citrate salt) 
The investigational product will be provided as open-label supplies, which will be dispensed by a 
pharmacist or designee at the site. 
12.2. 
Study Drug Packaging and Labeling 
The Sponsor will provide the study site with adequate clinical supplies including: 150-mg 
ibrexafungerp tablets of the citrate salt formulation. 
12.2.1. 
Bulk Container 
The container labels for the initial drug supply may contain information similar to the following: 
• Sponsor Name:  SCYNEXIS, Inc. 
• Study Protocol Number 
• Product name and potency:  150-mg ibrexafungerp tablets (as citrate salt) 
• Storage conditions:  Room Temperature (15° C to 25°C) 
• Dosing instructions:  Administer per protocol 
• Caution Statement: "Caution:  New Drug – Limited by Federal (United States) Law to 
Investigational Use Only” 
12.3. 
Study Drug Storage 
The primary investigator (or designee) at the clinical research site will be responsible for the 
proper storage of the study drugs. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
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For long-term storage, at the site pharmacy, ibrexafungerp study drug supplies will be kept in a 
secure area (eg, locked cabinet) and stored at room temperature (15°C to 25°C) and protected 
from moisture. The site will be required to keep a temperature log to establish a record of 
compliance with these storage conditions. For short-term storage once dispensed for the 
participant, ibrexafungerp tablets may be stored under ambient conditions. 
12.4. 
Study Drug Preparation and Administration 
Ibrexafungerp will be supplied as open label 150-mg tablets. 
Two 150-mg tablets will be administered for the 300-mg doses on Day 1 BID doses. Doses will 
be administered Q12H. The date and time of dose administration will be recorded on the eCRFs. 
Each participant will take their doses in a sitting posture with 240 mL of room temperature water 
30 minutes after starting to eat a standard meal. 
12.5. 
Study Drug Accountability 
Receipt and dispensing of study medications must be recorded by an authorized person at the 
investigator's site. 
The investigator agrees neither to dispense the study drug from, nor store it at any site(s) other 
than those listed on the Form Food and Drug Administration (FDA) 1572 or Investigator’s 
Agreement. The investigator agrees that study drug(s) will be dispensed by the investigator or 
sub-investigator(s) named on the Form FDA 1572 or Investigator’s Agreement, or their qualified 
designees. 
Accurate and current accounting of the dispensing of investigational product will be maintained 
on an ongoing basis by a member of the trial site staff: 
• Investigational medicinal product dispensed to each participant will be recorded in 
the trial-specific accountability log. 
• Accountability for any drug returned by participants will also be accounted for. 
12.6. 
Study Drug Handling and Disposal 
The following must be kept by the site until after the study has concluded and the sponsor or 
designee has completed final drug accountability and signed off on drug supply return. The study 
site should then have the used and unused supplies properly disposed of and fully document this 
process. 
• Unused 150-mg ibrexafungerp Tablets (Citrate Formulation) 
Copies of the destruction or drug return records should be returned to the sponsor. 
A final inventory of the total amount of investigational products received at the trial site against 
the amount used and destroyed must be recorded in the accountability log. Inventory records 
must be readily available for inspection by the trial monitor and/or auditor, and open to 
government inspection at any time. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
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13. 
PHARMACOKINETIC ASSESSMENTS 
13.1. 
Blood Sample Collection 
Blood samples will be collected at timepoints specified in the Schedule of Assessments 
(Table 5). 
13.2. 
Breast Milk Collection 
Electronic breast pumps will be provided to the participants. Breast milk samples will be 
collected at time intervals specified in the Schedule of Assessments (Table 5). The milk should 
be pumped/expressed completely from both breasts at the time intervals specified. The date, 
time, and volume of milk expressed will be collected and recorded on the eCRF. 
NOTE:  No breast milk, after the pumping prior to the Day 1 AM dose through the poststudy 
visit, should be provided to an infant. 
13.3. 
Sample Data 
Individual participant plasma and breast milk concentrations, actual milk and blood sampling 
times, actual volume of milk collected per interval, actual dosing information (actual time and 
date of dosing, and actual dose taken), and PK parameters for individuals and the group will be 
listed in tabular format. 
14. 
ASSESSMENT OF SAFETY 
14.1. 
Safety Parameters 
The safety and tolerability of ibrexafungerp will be monitored by clinical assessment of adverse 
experiences and by clinical and laboratory measurements, including vital signs (heart rate, blood 
pressure, and temperature), physical examinations, and laboratory safety tests Table 5. 
14.1.1. 
Demographic/Medical History 
During screening, a complete medical history for the prior 1 year will be recorded for each 
participant. Medical history will include previous and current medical diagnoses, major surgical 
procedures as well as pregnancy, postpartum, and lactation history Table 5. 
14.1.2. 
Vital Signs 
Vital signs, including blood pressure (BP systolic and diastolic), heart rate, respiratory rate, and 
body temperature will be measured at the time points indicated in the Schedule of Assessments 
in Table 5. 
Participants should be resting in a semi-recumbent position for at least 10 minutes prior to 
having vital sign measurements obtained. Semi-recumbent vital signs will include HR and BP. 
The method for temperature collection will be oral or tympanic. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
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14.1.3. 
Weight and Height 
Weight and height will be measured at the time points indicated in the Schedule of Assessments 
in Table 5. 
Body weight and height will be obtained with the participant’s shoes off and jacket or coat 
removed. 
14.1.4. 
Physical Examination and Physical Activity Questioning 
A standard physical examination will be performed at the time points indicated in the Schedule 
of Assessments in Table 5. 
The examination will include assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, 
lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities. 
Interim physical examinations will be performed at the discretion of the investigator, if 
necessary, to evaluate AEs or clinical laboratory abnormalities. 
Participants will also be questioned as to any strenuous physical activity done prior to clinical 
admission. If strenuous physical activity was performed the investigator must notify the Sponsor 
prior to dosing the participant. 
14.1.5. 
Electrocardiogram (ECG) 
A 12-lead ECG will be obtained and evaluated by a physician for the presence of abnormalities 
at the time points indicated in the Schedule of Assessments in Table 5. 
Special care must be taken for proper lead placement. Participants should be resting in a 
semi-recumbent position for at least 10 minutes prior to having ECG readings obtained. 
14.1.6. 
Laboratory Assessments 
Blood and urine samples for laboratory assessments will be collected at the time points indicated 
in the Schedule of Assessments in Table 5. Participants will not be required to fast prior to 
collecting blood and urine for laboratory safety tests. At screening a full set of laboratory tests 
(hematology, coagulation, chemistry and urinalysis) will be assessed; at pre-dose only 
hematology, AST, ALT, and bilirubin will be assessed; and at poststudy only hematology and 
clinical chemistry will be assessed (coagulation will not be required). 
All laboratory hematology, coagulation, urinalysis, and chemistry values must be within normal 
limits or not clinically significant as determined by the investigator for the participant to be 
included in this study. Throughout the study clinical laboratory values will be reviewed by the 
investigator for significance and consideration as an AE. “Out of Range” values will be 
determined and reported by the laboratory performing the test as high or low with respect to the 
normal range for each laboratory value. Clinically significant laboratory test value abnormalities 
should be reported on the AE page of the eCRF as adverse events if they are determined to be 
clinically significant by the investigator. 
14.1.6.1. Hematology 
Hematology includes the following assessments: 
White blood cell (WBC) count  
Hemoglobin (HgB) 


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US IND Number 107,521 
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13 March 2024 
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Red blood cell (RBC) count  
Hematocrit (Hct) 
Platelet count 
 
Differential white blood cell count will include percentages for segmented neutrophils, lymphocytes, 
monocytes, eosinophils, and basophils and absolute counts for neutrophils, lymphocytes, monocytes, 
eosinophils, and basophils. 
14.1.6.2. Coagulation 
The coagulation profile includes the following assessments: 
Prothrombin time (PT) 
Activated partial thromboplastin time (aPTT) 
Prothrombin time with international normalized ratio (INR) 
14.1.6.3. Blood Chemistry 
Biochemistry testing includes the following assessments performed (fasting is not required for 
this study): 
Alanine aminotransferase (ALT) 
Magnesium 
Albumin 
Phosphorus 
Alkaline phosphatase 
Potassium 
Aspartate aminotransferase (AST) 
Sodium 
Bicarbonate 
Total bilirubina 
Calcium 
Total creatine phosphokinase (CPK) 
Chloride 
Total Protein 
Cholesterol 
Triglycerides (TG) 
Creatinine 
Urea 
 
Gamma-glutamyl transferase (GGT) 
a Bilirubin will be fractionated if total bilirubin is elevated. For all total bilirubin results above the upper limit of 
normal, obtain direct bilirubin value, including at screening and poststudy. 
14.1.6.4. Urinalysis 
Urinalysis includes the following assessments: 
Dipstick: 
Microscopic: 
Protein 
WBC 
Glucose 
RBC 
pH 
Epithelial cells 
 
Casts (specify) 
14.1.6.5. Alcohol and Urine Drug Screens 
Alcohol, and urine drug screens (site standard urine drug screen) will be collected at the time 
points indicated in the Schedule of Assessments in Table 5. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
Page 41 
14.1.6.6. Virus Serology 
HIV/Hepatitis screens will be collected at the time points indicated in the Schedule of 
Assessments in Table 5. 
14.1.6.7. Pregnancy Screen 
Pregnancy tests will be collected at the time points indicated in the Schedule of Assessments in 
Table 5. The serum pregnancy testing will have a sensitivity of at least 25 mIU/L. 
14.1.6.8. COVID Screen 
COVID testing will be performed per the site’s protocol at the time points indicated in the 
Schedule of Assessments in Table 5. 
14.1.6.9. Adverse Event and Concomitant Medication Assessments 
Adverse events will be collected from the time of informed consent throughout the study, up 
through the poststudy visit. 
All medications (both prescription and OTC) taken within 14 days before dosing with study 
medication throughout the study, and through poststudy visit will be recorded on the eCRF. 
14.1.7. 
Blood Volume Requirements 
Approximately 116.5 mL of blood will be collected from participants (see Table 6). 
Table 6: 
Blood Volume Table 
Laboratory Test 
Number of 
Collections 
Amount per 
Collection 
Total Amount per 
Participant 
Laboratory safety tests  
3 
15.5 mL 
46.5 mL 
Blood for ibrexafungerp 
concentration 
10 
4 mL 
40 mL 
Serum for β-hCG test 
3 
10 mL 
30 mL 
TOTAL 
 
 
116.5a 
a If additional pharmacokinetic and/or safety analysis is necessary, additional blood (up to 25 mL) may be obtained. 
14.2. 
Adverse and Serious Adverse Events 
14.2.1. 
Definition of Adverse Events 
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether 
or not considered drug related. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of a study drug/study intervention, whether or not related to the study drug/study 
intervention. 
Any laboratory abnormality that is deemed to be clinically significant in the opinion of the 
investigator will be considered an adverse event and should be recorded in the eCRF, whether or 
not it is related to study drug. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
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Stable chronic conditions that are present prior to clinical trial entry and do not worsen are not 
considered adverse events and will be accounted for in the participant’s medical history. 
The following can be considered AEs: 
• An exacerbation of a pre-existing illness 
• An increase in frequency or intensity of a pre-existing episodic event or condition 
• A condition detected or diagnosed after the initiation of treatment with study 
medication, even though it may have been present prior to the start of the study 
• Continuous persistent disease or symptoms present at baseline that worsen after 
informed consent or following the initiation of treatment with study medication 
The following are not considered AEs: 
• Medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, or 
transfusion); the condition that leads to the procedure is an AE 
• Pre-existing disease or conditions present or detected at the start of the study that do 
not worsen 
• Situations where an untoward medical occurrence has not occurred (eg, 
hospitalizations for cosmetic surgery or elective surgery or social/convenience 
admissions) 
14.2.1.1. Serious Adverse Event (SAE) 
A serious adverse event is an AE occurring during any study phase (ie, baseline, treatment, or 
follow-up), and at any dose of the investigational product, comparator or placebo, that fulfils one 
or more of the following: 
• Results in death 
• It is immediately life-threatening 
• It requires in-patient hospitalization or prolongation of existing hospitalization 
• It results in persistent or significant disability or incapacity or substantial disruption 
of the ability to conduct normal life functions 
• Results in a congenital abnormality or birth defect 
• It is an important medical event that may jeopardize the participant or may require 
medical intervention to prevent one of the outcomes listed above. 
All SAEs that occur after any participant has been enrolled, before treatment, during treatment, 
through the post-study visit following the cessation of treatment, whether or not they are related 
to the study, must be recorded on forms provided by SCYNEXIS, Inc. 
14.2.1.2. Other Adverse Event (OAE) 
OAEs will be identified by the Drug Safety Physician and if applicable also by the Clinical Study 
Team Physician during the evaluation of safety data for the Clinical Study Report. Significant 
adverse events of particular clinical importance, other than SAEs and those AEs leading to 
discontinuation of the participant from the study, will be classified as OAEs. For each OAE, a 
narrative may be written and included in the Clinical Study Report. 
Events of Clinical Interest 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
Page 43 
The following are considered events of clinical interest (ECIs), and must be reported within 
24 hours of the site becoming aware of the ECI: 
• Overdose 
• ALT or AST >3 x ULN, confirmed by repeat 
• Hypersensitivity Reactions 
Overdose 
An overdose occurs if a participant has taken, accidentally or intentionally, any drug 
administered as part of the protocol in a dose exceeding that prescribed by the protocol. An 
overdose (and any associated AE) is considered an ECI and must be reported within 24 hours of 
the site becoming aware of the overdose. 
14.2.2. 
Unexpected Adverse Event 
An AE is considered “unexpected” if it is not listed in the Brexafemme® Package Label, 
Investigator’s Brochure (IB), or is of greater specificity or severity than has been observed with 
the particular study drug being tested. For example, under this definition, hepatic necrosis would 
be unexpected (by virtue of greater severity) if the IB referred only to elevated hepatic enzymes 
or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected 
(by virtue of greater specificity) if the investigator’s brochure listed only cerebral vascular 
accidents. "Unexpected," as used in this definition, also refers to AEs that are mentioned in the 
IB as occurring with a class of drugs or as anticipated from the pharmacological properties of the 
drug but are not specifically mentioned as occurring with the particular drug under investigation. 
14.2.3. 
AE and SAE Follow-up 
All AEs and SAEs will be followed to resolution (the participant’s health has returned to his or 
her baseline status or all variables have returned to normal) or until an outcome is reached, 
stabilization occurs (the investigator does not expect any further improvement or worsening of 
the event), or the event is otherwise explained, regardless of whether the participant is still 
participating in the study. All appropriate therapeutic measures should be undertaken and 
recorded. Where appropriate, medical tests and examinations will be performed to document 
resolution of the event(s). 
One of the following terms should be used to report the outcome of an event: 
Recovered/Resolved: The event has fully recovered. If the event was a worsening of an 
underlying medical condition, the event is considered recovered when the condition has returned 
to the initial level. 
Not recovered/Not resolved: The event was ongoing at the time of the report. 
14.2.4. 
Medical Emergencies 
All equipment, supplies, and the properly skilled medical personnel must be accessible for an 
adverse event requiring immediate treatment. 
After a medical emergency has been safely managed, it needs to be reported as soon as possible, 
but within 24-hours to the safety physician, the SCYNEXIS, Inc. medical monitor and any 


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US IND Number 107,521 
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appropriate reporting done to the ethics committee and the appropriate regulatory agencies in the 
necessary time frames. 
14.2.5. 
Protocol Deviations for an Adverse Event 
In the event of an adverse event or medical emergency, allowing departures from the protocol 
will be decided on a case-by-case basis. The Investigator or other physician in attendance in such 
an emergency must contact the SCYNEXIS, Inc. medical monitor, as soon as possible after the 
medical emergency has been managed, to discuss the circumstances of the emergency. The 
Investigator, in consultation with the SCYNEXIS, Inc. medical monitor, will decide whether the 
participant should continue to participate in the study. The Investigator and the SCYNEXIS, Inc. 
medical monitor will document this decision. The Investigator will inform the ethics committee 
of all protocol deviations in accordance with the ethics committee established procedure. No 
deviations from the protocol of any type will be made without complying with all ethics 
committee -established procedures. 
14.2.6. 
Additional Needed Clinical Laboratory Tests 
Clinical laboratory tests other than those specified in the protocol may be performed to ensure 
the safety of the participants. Those circumstances and data (dates, times, tests and all notes and 
results) will be documented on an eCRF. 
14.2.7. 
Relationship to Study Drug 
An Investigator who is qualified in medicine must make the determination of relationship to the 
investigational product for each AE (Unrelated, Possibly Related or Probably Related). The 
Investigator should decide whether, in his or her medical judgment, there is a reasonable 
possibility that the event may have been caused by the investigational product. If no valid reason 
exists for suggesting a relationship, then the AE should be classified as “unrelated.” If there is 
any valid reason, even if undetermined, for suspecting a possible cause-and-effect relationship 
between the investigational product and the occurrence of the AE, then the AE should be 
considered “related”. 
If the relationship between the AE/SAE and the investigational product is determined to be 
“possible” or “probable” the event will be considered to be related to the investigational product 
for the purposes of expedited regulatory reporting. 
14.2.8. 
Recording Adverse Events 
Adverse events spontaneously reported by the participant and/or in response to an open question 
from the study personnel or revealed by observation will be recorded during the study at the 
investigational site. Clinically significant changes in laboratory values, blood pressure, and pulse 
need not be reported as AEs. However, abnormal values that constitute an SAE or lead to 
discontinuation of administration of study drug must be reported and recorded as an AE. 
Information about AEs will be collected from the time informed consent is obtained up through 
the poststudy visit. Serious Adverse Event information will be collected from time informed 
consent is obtained through the poststudy visit. The AE term should be reported in standard 
medical terminology when possible. For each AE, the investigator will evaluate and report the 


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US IND Number 107,521 
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13 March 2024 
CONFIDENTIAL 
Page 45 
onset (date and time), resolution (date and time), intensity, causality, action taken, serious 
outcome (if applicable), and whether or not it caused the participant to discontinue the study. 
Intensity will be assessed according to the following scale: 
• Mild (awareness of sign or symptom, but easily tolerated) 
• Moderate (discomfort sufficient to cause interference with normal activities) 
• Severe (incapacitating, with inability to perform normal activities) 
It is important to distinguish between serious and severe AEs. Severity is a measure of intensity 
whereas seriousness is defined by the criteria under Section 14.2.1.1. An AE of severe intensity 
may not be considered serious. 
Should a pregnancy occur, it must be reported and recorded on SCYNEXIS, Inc.’s pregnancy 
form. Pregnancy in itself is not regarded as an AE unless there is a suspicion that an 
investigational product may have interfered with the effectiveness of a contraceptive medication. 
The outcome of all pregnancies (spontaneous miscarriage, elective termination, normal birth or 
congenital abnormality) must be followed up and documented even if the participant was 
discontinued from the study. 
All reports of congenital abnormalities/birth defects are SAEs. Spontaneous miscarriages should 
also be reported and handled as SAEs. Elective abortions without complications should not be 
handled as AEs. 
14.2.9. 
Reporting Adverse Events 
All SAEs will be reported as per Appendix B. All SAEs (related and unrelated) will be recorded 
from the time informed consent is obtained through 30-days after the last dose of study 
medication. following the end of treatment exposure. Any SAEs considered possibly or probably 
related to the investigational product and discovered by the Investigator at any time after the 
study should be reported. All SAEs must be reported to SCYNEXIS., Inc. within 24-hours of the 
first awareness of the event. The Investigator must complete, sign and date the SAE pages, verify 
the accuracy of the information recorded on the SAE pages with the corresponding source 
documents, and email or send a copy by fax to SCYNEXIS, Inc. as per Appendix B. 
Additional follow-up information, if required or available, should all be emailed or faxed to 
SCYNEXIS, Inc. as per Appendix B within one business day of receipt and this should be 
completed on a follow-up SAE form and placed with the original SAE information and kept with 
the appropriate section of the CRF and/or study file. 
The clinical research unit is responsible for notifying the relevant regulatory authorities of 
certain events. It is the Principal Investigator’s responsibility to notify the IRB or IEC of all 
SAEs that occur at his or her site. Investigators will also be notified of all unexpected, serious, 
drug-related events (7/15 Day Safety Reports) that occur during the clinical trial. Each site is 
responsible for notifying its IRB or IEC of these additional SAEs. 


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15. 
STATISTICS 
15.1. 
Analytical Plan 
All analyses will be conducted in accordance with this study protocol and a Statistical Analysis 
Plan (SAP) and Tables, Listings, and Figures (TLF) shells which will be prepared and approved 
by the sponsor prior to database lock. The study objectives are in found in Section 8. 
15.2. 
Sample Size Determination 
There is no formal power calculation. The N is based on practical aspects of recruitment in this 
this population. A sample size of up to 10 participants to complete the study is selected. 
15.3. 
Safety Analyses 
All adverse events and other safety evaluations (vital signs and clinical safety laboratory tests) 
will be listed by participant and tabulated for the total number of participants: 
All Participants: 
All adverse events will be coded using the most recent version of the Medical Dictionary for 
Regulatory Activities (MedDRA). The treatment emergent adverse events (TEAE) will be 
summarized by system order class (SOC) and preferred term. 
Summary statistics and plots will be generated for other safety parameters, including the absolute 
values and change from baseline values. Some parameters may need to use log scale. It is 
expected that both the log scale and back-transformed are needed for reporting. No statistical 
testing will be performed for the safety analysis. 
15.4. 
Pharmacokinetic Analysis 
Breast milk will be obtained up to 108 hours post dose and blood samples will be obtained 
starting pre dose the Day 1 morning dose until 108 hours post first dose of study drug for 
determination of ibrexafungerp concentrations. Sample time points are as follows: 
• Breast Milk:  complete expression of milk from both breasts (using a standard electric 
breast pump) will be obtained at the following timepoints and intervals: pre-dose, 0-2, 
2-4, 4-8, 8-12, 12-18, 18-24, 24-36, 36-48, 48-72, and 72-108 hours post first dose of 
study drug. 
• Plasma samples will be obtained at the following timepoints:  0 hours (prior to first 
dose), and at 2, 6, 8, 12 (prior to second dose), 24, 36, 48, 72, and 108 hours post first 
dose of study drug for determination of ibrexafungerp in plasma concentrations. The 
12-hour samples will be taken prior to the second dose of ibrexafungerp. 
The following plasma ibrexafungerp pharmacokinetic parameters: area under the curve (AUC), 
peak plasma concentration (Cmax), time to peak plasma concentration (Tmax), plasma clearance or 
apparent oral clearance (CL/F), apparent volume of distribution (Vd), and terminal half-life (t1/2) 
for ibrexafungerp following oral administration of the VVC dosage regimen for ibrexafungerp 
will be determined for both breast milk and plasma concentrations. 


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US IND Number 107,521 
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13 March 2024 
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The following PK parameters of ibrexafungerp in breastmilk:  AUC for the different collection 
periods, Cav based on AUC derived from collections at different time points; total milk 
concentration data will be used to calculate Cmax, Cmin and Tmax. 
The daily infant dosage (total drug present in milk and consumed by the infant per day) will be 
calculated: 
• Daily Infant Dosage (mg/day) = Σ (total drug concentration in each milk collection 
multiplied by the expressed milk volume in each milk collection)  
The M/P will be calculated. M/P = AUC0-24 milk/AUC0-24 plasma. 
The calculation of M/P should be based on AUC and on multiple time points over 24 hours and 
not just a single point in time. 
The relative infant dose (the percent of the weight-adjusted maternal dosage consumed in breast 
milk over 24 hours) will be calculated: 
• Relative Infant Dose = Infant Dosage (mg/kg/day)/Maternal Dosage (mg/kg/day) 
multiplied by 100. 
Individual participant plasma and breast milk concentrations, actual breast milk and blood 
sampling dates and times, actual volume of breast milk collected at each time interval, actual 
dosing information (actual time and date of dosing, and actual dose taken), and PK parameters 
for individuals and the group will be listed in tabular format. Plasma and breast milk 
concentrations measured over time will be displayed graphically. Plasma and breast milk 
concentrations and PK parameters will be summarized using descriptive statistics. 
The PK of ibrexafungerp plasma and breastmilk will be assayed using validated LC-MSMS 
methods. 
15.5. 
Interim Analysis 
An interim analysis will be conducted after five participants have completed their participation in 
the study. The analysis will involve the examination of pharmacokinetic and safety data and will 
comprise a full analysis as described in the SAP. The objective of the interim analysis is to 
determine whether the data from 5 participants is sufficient to address the objectives of the study 
and fulfill the post marketing requirement (PMR 4069-2); if not the study shall continue to 
recruit up to 10 participants. 
The reporting analysis will involve descriptive statistical methods, including summaries, 
tabulations, graphs, or by-subject listings. Before initiating this analysis, the data for the study 
endpoints will undergo a thorough cleaning process, and the database will be soft-locked. The 
SAP will be finalized before database lock. 
16. 
STUDY COMPLETION AND TERMINATION 
Study completion is defined as the date the last participant completes the final visit in the study. 
Given the unpredictable nature of early Phase 1 studies, it may exceptionally be necessary to 
keep the study open for gathering/reviewing additional supportive data (preclinical and/or 
clinical) to optimally complete the objective(s) of the study. In this case, the competent authority 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
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13 March 2024 
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Page 48 
and the ethics committee will be appraised of the maximum extension of the duration of the 
study beyond the last participant out and the justification for keeping the study open. If 
necessary, appropriate amendments to the protocol will be generated. 
Study termination is defined as a permanent discontinuation of the study due to unanticipated 
concerns of safety to the study participants or availability of other new data (pharmacokinetic, 
pharmacodynamic, efficacy, biologic, etc.) arising from clinical or preclinical studies with this 
study drug. A study may be paused during review of newly available preclinical/clinical safety, 
pharmacokinetic, pharmacodynamic, efficacy, or biologic data, or other issues of interest or 
potential concern prior to a final decision for continuation or termination of the study. 
16.1. 
Study Termination 
The principal investigator, the sponsor, the regulatory authority, and the IRB/EC each reserve the 
right to terminate the study in the interest of participant’s safety and welfare. The sponsor 
reserves the right to terminate the study at any time for administrative reasons. 
17. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
17.1. 
Study Monitoring 
Before an investigational site can enter a participant into the study SCYNEXIS, Inc. or its 
responsible CRO will follow their standard operating procedures (SOPs) for site qualification 
and initiation. 
Study progress will be monitored by the sponsor or its representative as frequently as necessary 
to ensure adequate and accurate data collection, protocol compliance, and study conduct in 
accordance with accepted regulatory requirements. The principal investigator must make all the 
participant data available to the study monitor for review during the site monitoring visits. 
Arrangements for monitoring visits will be made in advance, except in emergency cases. 
17.2. 
Investigator Study Files 
The principal investigator is responsible for maintaining all study-related documents in study 
files. The sponsor will notify the principal investigator when retention of study files is no longer 
necessary. The following documents will be kept in the study files or be readily accessible: 
• original protocol and all amendments; 
• signed agreement or protocol; 
• signed and dated study staff roles and responsibilities log; 
• copy of the current curriculum vitae of the principal investigator and of all 
sub-investigators 
• IRB/EC description of the number of members in each category, their area of 
specialty and qualifications; 
• All IRB/EC approvals for the protocol and amendments, informed consent 
documentation and all updates, advertisements, and written information provided to 
participants; all IRB/EC correspondence; documentation that the IB and subsequent 
revisions have been submitted to the IRB/EC; documentation that all SAEs and any 


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periodic safety reports have been submitted to the IRB/EC; and annual IRB/EC 
renewals (as required); 
• up-to-date laboratory certification and the laboratory’s normal values (covering the 
entire time interval of the study for all laboratory tests conducted during the study); 
• all confirmations of investigational drug receipt, drug accountability logs, and drug 
return records; 
• a CD containing final participant eCRF data; 
• all correspondence to or from the sponsor or its designees; 
• blank informed consent form; 
• Investigator’s Brochure; 
• participant screening log; 
• participant list (contains participant initials and/or protocol-specific participant 
number); 
• all participants’ original signed informed consents; and, 
• monitoring visit log. 
17.3. 
Audits and Inspections 
Authorized representatives of SCYNEXIS, Inc., a regulatory authority, an Independent Ethics 
Committee or an Institutional Review Board may visit the site to perform audits or inspections, 
including source data verification. The purpose of an SCYNEXIS, Inc. audit or inspection is to 
systematically and independently examine all study-related activities and documents to 
determine whether these activities were conducted, and data were recorded, analyzed, and 
accurately reported according to the protocol, Good Clinical Practice guidelines of the 
International Conference on Harmonization, and any applicable regulatory requirements. The 
investigator should contact SCYNEXIS, Inc. immediately if contacted by a regulatory agency 
about an inspection. 
17.4. 
Institutional Review Board (IRB)/ Ethics Committee (EC) 
The Principal Investigator must obtain IRB/EC approval for the investigation. Initial IRB 
approval, and all materials approved by the IRB/EC for this study including the participant’s 
assent, parental consent forms, and recruitment materials must be maintained by the Investigator 
and made available for inspection. 
18. 
QUALITY CONTROL AND QUALITY ASSURANCE 
To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, 
SCYNEXIS, Inc. or its representatives may conduct a quality assurance audit. Please see 
Section 17.3 for more details regarding the audit process. 


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19. 
ETHICS 
19.1. 
Ethics Review 
The final study protocol, including the final version of the Informed Consent Form, must be 
approved or given a favorable opinion in writing by an IRB or IEC as appropriate. The 
investigator must submit written approval to SCYNEXIS, Inc. before he or she can enroll any 
participant into the study. 
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the 
protocol in accordance with local requirements. In addition, the IRB or IEC must approve all 
advertising used to recruit participants for the study. The protocol must be re-approved by the 
IRB or IEC upon receipt of amendments and annually, as local regulations require. 
The Principal Investigator is also responsible for providing the IRB with reports of any 
reportable serious adverse drug reactions from any other study conducted with the investigational 
product. SCYNEXIS, Inc. will provide this information to the Principal Investigator. 
Progress reports and notifications of serious adverse drug reactions will be provided to the IRB 
or IEC according to local regulations and guidelines. 
19.2. 
Ethical Conduct of the Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable 
regulatory requirements. 
19.3. 
Written Informed Consent 
The Principal Investigator(s) or representative(s) at each center will ensure that the participant is 
given full and adequate oral and written information about the nature, purpose, possible risk and 
benefit of the study. Participants must also be notified that they are free to discontinue from the 
study at any time. The participant should be given the opportunity to ask questions and allowed 
time to consider the information provided. 
The participant’s signed and dated informed consent must be obtained before conducting any 
study procedures. 
The Principal Investigator(s) must maintain the original, signed Informed Consent Form. A copy 
of the signed Informed Consent Form must be given to the participant. 
19.4. 
Participant Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records that leave the site will be 
identified only by a coded number to maintain participant confidentiality. All records will be 
kept in a locked file cabinet. All computer entry and networking programs will be performed 
with coded numbers only. Clinical information will not be released without written permission of 
the participant, except as necessary for monitoring by the medical monitor, IRB/EC, the FDA, or 
the sponsor. 


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19.5. 
Financial Disclosure 
The financial interests of all investigators from all participating clinical centers must be collected 
prior to study initiation, immediately after the completion of the final follow-up visit for the last 
participant, and 1 year following the completion of the clinical trial. 
20. 
DATA HANDLING AND RECORDKEEPING 
20.1. 
Inspection of Records 
SCYNEXIS, Inc. or regulatory authorities will be allowed to conduct site visits to the 
investigation facilities for the purpose of monitoring any aspect of the study. The Investigator 
agrees to allow the inspection of the drug storage area, study drug stocks, drug accountability 
records, participant charts, study source documents, investigator study file documents, and other 
records relative to study conduct. 
20.2. 
Retention of Records 
The Principal Investigator must maintain all documentation relating to the study for a period of 
15 years after the end of the trial. If it becomes necessary for SCYNEXIS, Inc. or the Regulatory 
Authority to review any documentation relating to the study, the Investigator must permit access 
to such records. 


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21. 
LIST OF REFERENCES 
1. Foxman B, Marsh JV, Gillespie B, Sobel JD. Frequency and response to vaginal 
symptoms among white and African American women: results of a random digit dialing 
survey. J Womens Health 1998; 7:1167–74. 
2. Hurley R, De Louvois J. Candida vaginitis. Postgrad Med J 1979; 55:645–47. 
3. Pfizer Website. Diflucan prescribing information. Revised November 2014. 
4. Sobel JD, Management of recurrent vulvovaginal candidiasis: unresolved issues. Curr 
Infect Dis Rep. 2006 Nov; 8(6):481-6. 
5. Sobel JD. Vaginal candidiasis. Lancet 2007; 369:1961–71. 
6. FDA Guidance for Industry, Clinical Lactation Studies: Considerations for Study Design 
Guidance for Industry, May 2019. https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/clinical-lactation-studies-considerations-study-design  
7. US National Institute of Health Web site. US National Library of Medicine. Brexafemme 
Label. DailyMed - BREXAFEMME- ibrexafungerp tablet, film coated (nih.gov), 
Accessed 15 October 2021. 
8.  How to use a breast pump: 12 top tips. Medela website. 
https://www.medela.com/breastfeeding/mums-journey/how-to-use-breast-pump. 
Accessed May 13, 2022. 


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APPENDIX A. TIME WINDOWS FOR SERIAL ASSESSMENTS 
Plasma PK Sampling Timepoints 
PK Sampling Timepoint (measured from 
Day 1 zero hour) 
Tolerance Window 
<0 hour 
-120 minutes to 0 hour 
≥0 hour - 108 hour 
-5 minutes to +5 minutes 
Breast Milk PK Sampling Timepoints 
PK Sampling Timepoint (measured from 
Day 1 zero hour) 
Tolerance Window 
<0 hour 
-20 minutes to 0 hour 
≥0 hour - 108 hour 
-5 minutes to +5 minutes 
Vital Signs and Temperature Timepoints 
Vital Signs Timepoint  
Tolerance Window 
<0 hour 
-12 hours to 0 hour 
≥0 hour - 108 hour 
-20 minutes to +20 minutes 


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APPENDIX B. SERIOUS ADVERSE EVENT REPORTING 
SAEs, as defined in Section 14.2 Adverse and Serious Adverse Events will be reported in 
accordance with ICH E2A Clinical Safety Data Management: Definitions and Standards for 
Expedited Reporting. 
Site Responsibilities 
All SAEs that occur during the course of the study must be reported to SCYNEXIS within 
24 hours of the knowledge of the occurrence. 
The Investigator will fill out the SAE form and provide as complete information as are available. 
At a minimum, participant number, the dates and times of the study drug administered, a 
narrative description of the event must be provided. An assessment by the Investigator as to the 
severity of the event and relatedness to study drug should also be provided, if possible. 
Investigator will report all SAEs to: 
AWINSA 
at 
sae@scynexis.com 
Telephone: +1.201.884.2243 
The investigator will report SAE and any follow up information to the Clinical Research 
Regulatory Council (CRRC) as per the CRRC’s procedures and requirements. 
The investigator will provide SAE follow-up information as soon as information is available to 
SCYNEXIS. 
SCYNEXIS Responsibilities 
If the SAE is considered a Suspected, Unexpected Serious Adverse Reaction (SUSAR) 
SCYNEXIS will create a Council for International Organizations of Medical Sciences (CIOMS) 
form or a Medwatch 3500A Report for submission to the relevant regulatory authority within 
15-days after SCYNEXIS has learned of the SAE. If the SUSAR is a fatal or life-threatening 
event, the reports will be sent within 7 days after SCYNEXIS has learned of the event. 
Follow-up reports will be provided to regulatory agencies as soon as information is available 
according to the same reporting periods. 


SCYNEXIS, Inc. 
 
US IND Number 107,521 
Clinical Protocol Number SCY-078-121 
13 March 2024 
CONFIDENTIAL 
Page 55 
Appendix C. 
PROHIBITED MEDICATIONS 
Strong CYP3A4/5 Inhibitors and CYP3A4/5 Inducers 
• CYP3A4/5 Strong/Moderate Inhibitors 
• CYP3A4/5 Reversible Inhibitors 
Boceprevir, conivaptan, indinavir, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, 
nelfinavir, telaprevir, telithromycin, itraconazole, posaconazole, and voriconazole 
• CYP3A4/5 Time Dependent Inhibitors 
Clarithromycin, ritonavir, and saquinavir 
• CYP3A4/5 Inducers 
Avasimibe, carbamazepine, phenytoin, rifampin, and St. John’s wort 

SAP_001.pdf: 
SCYNEXIS, Inc. 
Statistical Analysis Plan – Final 
Protocol No. SCY-078-121 
Page 1 of 26 
Confidential 
 
 
 
 
 
 
 
Statistical Analysis Plan 
 
 
Protocol No. SCY-078-121, Version 4 (Amendment 3), 
13 March 2024 
 
 
 
An Open-Label Pharmacokinetic Study in Healthy Lactating  
Women after Two Oral Doses of Ibrexafungerp Administered on  
a Single Day 
 
 
 
 
 
 
Sponsor: 
SCYNEXIS, Inc. 
1 Evertrust Plaza, 13th Floor 
Jersey City, NJ 07302, USA 
Prepared by: 
EDETEK, Inc. 
101 College Road E 
Princeton, NJ 08540, USA 
Document status: 
Version 1.0 
Release date: 
25 March 2024 


SCYNEXIS, Inc. 
Statistical Analysis Plan – Final 
Protocol No. SCY-078-121 
Page 2 of 26 
Confidential 
 
 
Signature Page 
 
 
Authors: 
Ramesh Vishwakarma, 
PhD Statistician 
EDETEK, Inc. 
101 College Road E 
Princeton, NJ 08540 
Signature: ________________________ 
Date: 
 
Michael S. Willett, PharmD, RAC 
Pharmacokineticist 
Ready Clinical, LLC 
Signature: 
 
Date: 
 
Sponsor Representative: 
Michelle Middle, MD 
Medical Director, 
Clinical Development 
SCYNEXIS, Inc. 
Signature:_____________________ 
Date:___________________ _____ 
 
Version History 
Version Number 
Version Date 
Author 
Significant Changes from Previous Versions 
1.0 
25 March 2024 
Ramesh 
Vishwakarma 
(not applicable) 
 
 


SCYNEXIS, Inc. 
Statistical Analysis Plan – Final 
Protocol No. SCY-078-121 
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Confidential 
 
 
Table of Contents 
1 Introduction ........................................................................................................................ 8 
2 Study Objectives ................................................................................................................ 8 
2.1 Primary Objectives ............................................................................................................. 8 
2.2 Secondary Objectives ......................................................................................................... 8 
3 Study Endpoints ................................................................................................................. 8 
3.1 Primary Endpoints .............................................................................................................. 8 
3.2 Secondary Endpoints .......................................................................................................... 9 
4 Study Design and Methods ................................................................................................ 9 
4.1 Overall Study Design ......................................................................................................... 9 
4.2 Sample Size ...................................................................................................................... 12 
4.3 Treatment of Participants ................................................................................................. 12 
4.4 Randomization and Blinding ........................................................................................... 12 
4.5 Study Measurements ........................................................................................................ 12 
4.5.1 
Pharmacokinetic Measurements .......................................................................... 12 
4.5.2 
Safety Measurements .......................................................................................... 13 
4.6 Data Handling .................................................................................................................. 13 
5 Data Analysis ................................................................................................................... 13 
5.1 Analysis Populations ........................................................................................................ 13 
5.2 Study Participants ............................................................................................................. 14 
5.2.1 
Participant Disposition ........................................................................................ 14 
5.2.2 
Protocol Deviations ............................................................................................. 14 
5.2.3 
Participant Eligibility .......................................................................................... 14 
5.3 Participant Demographics ................................................................................................ 14 
5.4 Medical History ................................................................................................................ 14 
5.5 Prior and Concomitant Medications ................................................................................ 15 
5.6 Treatment Exposure and Compliance .............................................................................. 15 
5.7 Pharmacokinetic Analysis ................................................................................................ 15 
5.7.1 
Plasma and Breast milk Concentrations .............................................................. 15 
5.7.2 
Pharmacokinetic Parameters ............................................................................... 16 
5.8 Safety Analysis ................................................................................................................. 18 
5.8.1 
Adverse Events .................................................................................................... 18 
5.8.2 
Clinical Laboratory Assessments ........................................................................ 19 
5.8.3 
Vital Signs Assessments ...................................................................................... 20 
5.8.4 
Physical Examinations ........................................................................................ 20 
5.8.5 
Electrocardiogram (ECG) ................................................................................... 20 
5.9 Interim Analysis ............................................................................................................... 20 
5.10 
Statistical Programming and Deliverables .......................................................... 21 


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Protocol No. SCY-078-121 
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5.11 
Changes to the Planned Analysis ........................................................................ 22 
APPENDIX A. ADVERSE EVENTS DATE IMPUTATION .............................................. 23 
APPENDIX B. CONCOMITANT MEDICATIONS DATE IMPUTATION ....................... 25 
 


SCYNEXIS, Inc. 
Statistical Analysis Plan – Final 
Protocol No. SCY-078-121 
Page 5 of 26 
Confidential 
 
 
List of Tables 
Table 1 : 
Schedule of Assessments ..................................................................................... 10 
Table 2 : 
Investigational Product ....................................................................................... 12 
Table 3 : 
Pharmacokinetic Parameters ............................................................................. 16 
 
List of Figures 
Figure 1 Study Design  


SCYNEXIS, Inc. 
Statistical Analysis Plan – Final 
Protocol No. SCY-078-121 
Page 6 of 26 
Confidential 
 
 
List of Abbreviations 
Abbreviation 
Term 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AM 
Ante meridiem 
AST 
Aspartate aminotransferase 
AUC 
Area under the concentration-time curve 
AUC0-t 
Area under the concentration-time curve from 0 to t hours 
ATC 
Anatomical therapeutic class 
BID 
Twice a day 
BMI 
Body mass index 
BP 
Blood pressure 
BLQ 
Below the limit of quantification of the assay 
Cav 
Average concentration in breast milk during the dosing interval 
CI 
Confidence interval(s) 
CL/F 
Clearance 
Cmax 
Maximum concentration 
Cmin 
Minimum concentration 
CS 
Clinically significant 
CSP 
Clinical study protocol 
CV 
Coefficient of variation 
DBL 
Database lock 
ECG 
Electrocardiogram 
ECI 
Event of clinical interest 
EMA 
European Medicines Agency 
eCRF 
Electronic case report form 
FDA 
Food and drug administration 
GSD 
Geometric standard deviation 
GCV 
Geometric coefficient of variation 
HR 
Heart rate 
ICH 
International conference on harmonization 
MedDRA 
Medical dictionary for regulatory activities 
M/P 
Milk/Plasma 
μg 
Microgram 
μL 
Microliter 
mg 
Milligram 
mL 
Milliliter 


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ng 
Nanograms 
nM 
Nanomolar 
NR 
Not reportable 
NS 
No sample 
NCA 
Noncompartmental analysis 
OTC 
Over-the-counter 
PK 
Pharmacokinetics 
PM 
Post meridiem 
PT 
Preferred term 
Q12H 
Every 12 hours 
RR 
Respiratory rate 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SOC 
System organ class 
T 
Temperature 
TLF 
Tables, figures, and listings 
t½ 
Terminal half-life 
TEAE 
Treatment emergent adverse event 
Tmax 
Time to maximum concentration 
ULN 
Upper limit of normal 
WBC 
White blood cell 
Vd 
Volume of distribution 
VVC 
Vulvovaginal candidiasis 
 
 


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1 
Introduction 
The Statistical Analysis Plan (SAP) provides details of the planned analysis and reporting for 
Scynexis Inc. Protocol SCY-078-121 (An Open-Label Pharmacokinetic Study in Healthy 
Lactating Women after Two Oral Doses of Ibrexafungerp Administered on a Single Day), final 
version 4.0 (Amendment 3) dated 13-March-2024. 
The structure and content of this SAP provide sufficient details to meet the requirements 
identified by the Food and Drug Administration (FDA), European Medicines Agency (EMA), 
and International Conference on Harmonization (ICH) for statistical practice. 
The planned statistical methodology to be used in this SAP describes the main variables and 
populations, anticipated data transformation and manipulation methods, and other details of 
the analyses (for producing Tables, Figures, and Listings (TLFs)) not provided in the Clinical 
Study Protocol (CSP). 
The following documents were reviewed in preparation of this SAP: 
• Study Protocol, Version 4.0 (Amendment 3) (13 MAR 2024) 
• electronic Case Report Form (eCRF), Version 1.3 (18 OCT 2023) 
The SAP will be finalized prior to database lock (DBL) and describes the statistical analysis as 
it is foreseen when the study is being planned. If circumstances should arise during the study 
rendering this analysis inappropriate, or if improved methods of analysis should arise, updates 
to the analyses may be made. Any deviations from the SAP after DBL, reasons for such 
deviations, and all alternative or additional statistical analyses that may be performed will be 
described in an SAP Addendum and documented in the final clinical study report. 
2 
Study Objectives 
 
2.1 
Primary Objectives 
• To determine whether ibrexafungerp is excreted in breast milk and if so, to characterize 
ibrexafungerp pharmacokinetics (PK) in the breast milk and plasma of lactating 
women. 
 
2.2 
Secondary Objectives 
• To calculate the potential infant exposure to ibrexafungerp if lactating women are 
treated with ibrexafungerp. 
• To characterize the safety and tolerability of ibrexafungerp in lactating women. 
 
3 
Study Endpoints 
 
3.1 
Primary Endpoints 
• The plasma pharmacokinetic parameters: area under the curve (AUC), peak plasma 
concentration (Cmax), time to peak plasma concentration (Tmax), plasma clearance or 
apparent oral clearance (CL/F), apparent volume of distribution (Vd), and terminal 
half-life (t1/2). 
• The breast milk pharmacokinetic parameters: area under the curve (AUC) for the 


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different collection periods, average concentration (Cav), Cmax, Cmin, and Tmax. 
3.2 
Secondary Endpoints 
• Calculated Daily Infant Dosage (mg/day) after maternal ingestion for one day of 
300 mg BID ibrexafungerp dosing. 
• Calculated Relative Infant Dose (%) after maternal ingestion for one day of 300 mg 
BID ibrexafungerp dosing. 
• Safety and tolerability as measured by adverse events, vital signs, physical examination, 
and clinical laboratory assessments. 
4 
Study Design and Methods 
 
4.1 
Overall Study Design 
This is a Phase 1 study designed to determine whether the given oral dose of ibrexafungerp is 
excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and 
plasma of lactating women. 
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral 
ibrexafungerp doses given 12 hours apart (Q12H). Participants will receive both doses on site. 
Participants will be admitted to the clinic on Day 1, and may be discharged on Day 5, after the 
108-hour procedures are completed, at the discretion of the Investigator. 
Participants who discontinued may be replaced at the discretion of the investigator and Sponsor 
to ensure that up to 10 evaluable participants complete the study. The flow chart of the study 
design is given in Figure 1 and the Schedule of Assessments is provided in Table 1. 
Figure 1:: Study Design 
 
 


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Table 1 : Schedule of Assessments  
Study Procedures 
Screeninga 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Post-study 
Predoseb 
0 hr 
8 hr 
12 hr 
24 hr 
36 hr 
48 hr 
72 hr 
108 hr 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
 
 
Physical Examc 
X 
X 
 
 
 
 
 
 
 
X 
12-Lead ECGc 
X 
 
 
 
 
 
 
 
 
 
Enrollment 
 
X 
 
 
 
 
 
 
 
 
Demographics and Medical 
History prior 1 yr (including 
pregnancy, postpartum, and 
lactation history) 
X 
 
 
 
 
 
 
 
 
 
Height and Weightd 
X 
 
 
 
 
 
 
 
 
X 
Vital Signs (HR, BP)c 
X 
X 
 
X 
 
X 
 
 
 
X 
Vital Signs (RR, Temperature) 
X 
X 
 
 
 
 
 
 
 
X 
Safety laboratory testinge 
X 
X 
 
 
 
 
 
 
 
X 
HIV/Hepatitis Screen 
X 
 
 
 
 
 
 
 
 
 
COVID, Alcohol, and Urine drug 
screen (standard at site)f 
X 
X 
 
 
 
 
 
 
 
 
Pregnancy Tests (serum) 
X 
Xj 
 
 
 
 
 
 
 
X 
Standard Meals 
 
X-----------------------------------------------------------------------------------------------------------------X 
Study Drug Administrationg 
 
 
X 
 
X 
 
 
 
 
 
Blood Samples for Ibrexafungerp 
Concentrationh 
 
 
X-------------------------------------------------------------------------------------------X 
Breast Milk Samples for 
Ibrexafungerp Concentrationi 
 
 
X-------------------------------------------------------------------------------------------X 
Abbreviations: BP = blood pressure; HR = heart rate; RR = respiratory rate, PK = pharmacokinetic, ECG = electrocardiogram, and HIV = human immunodeficiency 
virus 
a Pre-study screening to determine eligibility may be performed within 4 weeks prior to dosing with study medication. 


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b The Day 1 predose examinations and assessments may be performed up to 12 hours predose. 
c During physical examination at screening and predose participants will also be asked about physical activity. Prior to ECG the participants must be in a semi-
recumbent position for at least 10 minutes prior to having heart rate, blood pressure, and ECG performed. 
d Height documented at screening only. 
e Participants will not be required to fast prior to collecting blood and urine for laboratory safety tests. At screening a full set of laboratory tests (hematology, 
coagulation, chemistry, and urinalysis) will be assessed; at pre-dose only hematology, AST, ALT, and bilirubin will be assessed; and at poststudy only hematology 
and clinical chemistry will be assessed (coagulation will not be required). 
f Urine drug and alcohol screening will be done at screening, within 12 hours before the first dose, and upon admission to the clinic. COVID-19 testing will be done 
per site requirements. 
g Ibrexafungerp 300-mg will be administered BID Q12H on Day 1 while the participant is in a semi-supine position with 240 mL of room temperature water. 
h Plasma samples will be obtained at the following timepoints:  0 hours (prior to first dose), and at 2, 6, 8, 12, 24, 36, 48, 72 and 108 hours post first dose of study drug 
for determination of ibrexafungerp in plasma concentrations. The 12-hour samples will be taken prior to the second dose of ibrexafungerp. 
i Breast Milk:  complete expression of milk from both breasts (using a standard electric breast pump) will be obtained at the following timepoint and intervals: pre-
dose, 0-2, 2-4, 4-8, 8-12, 12-18, 18-24, 24-36, 36-48, 48-72, and 72-108 hours post first dose of study drug. 
j Pregnancy test to be repeated if screening was more than 24 hours prior to Day 1 dosing. 
k Admission to the clinic will be prior to dosing on Day 1 (for participant, and infant if that is the participant’s choice). Infant admission is not mandatory, but the site 
will provide this option. The stay in the clinic will be through the Day 5, 108-hour, post-study procedures are complete. 


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4.2 
Sample Size 
There is no formal power calculation. The sample size (N) is based on practical aspects 
of recruitment in this population. A sample size of up to 10 participants to complete the 
study is selected. 
Up to t10 healthy lactating females who are at least 10 days postpartum with a full milk 
supply established and are between the ages of 18 and 50 years, inclusive, at the time of 
screening. Enough participants will be enrolled to complete up to 10 evaluable 
participants (meeting study inclusion/exclusion criteria specified in the protocol). 
 
4.3 
Treatment of Participants 
The Sponsor will provide the study site with adequate clinical supplies including: 
150-mg ibrexafungerp tablets of the citrate salt formulation. Participants will be assigned 
the investigational product (See Table 2). Please refer to the protocol on prior and 
concomitant medications use and the study restrictions. 
Table 2 : Investigational Product 
 
 
 
Investigational Product 
Product Name: 
Ibrexafungerp tablets (as citrate salt) 
Dosage Form: 
150-mg ibrexafungerp tablets (as citrate salt) 
Unit Dose: 
2 X 150-mg tablets for the 300-mg dose  
Route of Administration: 
Oral 
Physical Description: 
150-mg compressed tablets 
Manufacturer: 
SCYNEXIS, Inc. 
 
 
4.4 
Randomization and Blinding 
There is no randomization planned in the study. This is an open-label study. Each 
participant will be assigned a participant’s study number (in numerical order as they are 
enrolled) prior to dosing. The participant’s study number will be used to identify the 
participant for all procedures and in eCRF. 
4.5 
Study Measurements 
Study measurements are taken (see Table 1) on measurements collected by timepoint: 
• Prestudy Screening (Day -28 to Day -1) 
• Predose (Prior to Day 1 Morning Dosing) 
• Treatment Day 1 
• Day 2 (24-hours postdose) through Day 4 
• Day 5 (Post-Study) 
 
4.5.1 Pharmacokinetic Measurements 
For pharmacokinetic (PK) assessments, the concentration of ibrexafungerp will be 
obtained from the blood sample and breast milk sample. 


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The blood samples will be obtained at the following timepoints: 0 hours (prior to first 
dose), and at 2, 6, 8, 12 (prior to second dose), 24, 36, 48, 72 and 108 hours post first 
dose of study drug for determination of ibrexafungerp concentrations in plasma. The 
12-hour samples will be taken prior to the second dose of ibrexafungerp. 
In breast milk, complete expression of milk from both breasts (using a standard electric 
breast pump) will be obtained at the following timepoint and intervals: pre-dose, 0-2, 
2-4, 4-8, 8-12, 12-18, 18-24, 24-36, 36-48, 48-72, and 72-108 hours post first dose of 
study drug. 
4.5.2  Safety Measurements 
The safety and tolerability of ibrexafungerp will be monitored by clinical assessment of 
adverse experiences and by repeated clinical and laboratory measurements, including 
vital signs (heart rate, blood pressure, respiratory rate, and temperature), physical 
examinations, 12 lead electrocardiograms (ECGs), standard laboratory safety tests 
(hematology, coagulation, chemistry, and urinalysis). 
4.6 
Data Handling 
All participant data used for analysis will be displayed in listings. 
Summaries for continuous variables will include the descriptive statistics for number of 
participants (n), mean, standard deviation (SD), minimum (min), median, and maximum 
(max). For PK concentration and parameters, the summary table will also include 
statistics: percent coefficient of variation (CV%), geometric mean (GM), SD of GM 
(GSD) andpercent CV of GM (GCV%). Summaries for categorical (discrete) variables 
will include the number and/or percentage of participants in a particular category. When 
categorical data are presented, the percentage will be suppressed when the count is zero 
in order to draw attention to the non- zero counts. The denominator for all percentages, 
unless otherwise specified, will be the number of participants in the specified analysis 
population. 
For presentation of numeric data, minimum and maximum values will be presented to 
the same number of decimal places as the electronic Case Report Form (eCRF) data; 
means and medians will be presented to one more decimal place than the eCRF data; 
standard deviations will be presented to two more decimal places than the eCRF data. 
Baseline is defined as the last non-missing value measured prior to the first dose of study 
drug. Change from Baseline is defined as [Post-baseline Value – Baseline Value]. 
Statistical analyses and summaries will be performed using SAS® Version 9.3 or greater 
(SAS Institute). Pharmacokinetic analyses will be performed using Phoenix WinNonlin 
Version 8.4 (Certara USA, Inc.). 
5 
Data Analysis 
 
5.1 
Analysis Populations 
 
The following analysis population will be used to summarize the results from this study: 
• Enrolled Population: All participants who were signed informed consent 


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and met the study eligibility criteria. 
• Safety Population: All participants who were enrolled in the study and received 
at least a partial tablet of ibrexafungerp. No treated participants will be excluded 
from the safety population. 
• Pharmacokinetic Population: All participants who receive ibrexafungerp and 
who have at least one quantifiable PK parameter. 
Participants who are excluded from the analysis populations will be listed by participant 
and treatment. 
5.2 
Study Participants 
 
5.2.1 Participant Disposition 
The number and percentage of participants belongs to each analysis population as 
defined in Section 5.1 will be summarized and listed for all enrolled participants. 
Participant disposition will be summarized using the number of participants who were 
enrolled, the number and percent of participants who complete the study, the number and 
percent of participants who discontinue the study, and the reasons for discontinuation. 
The denominator of percentage will be the number of participants enrolled. Participant 
disposition and completion status will be listed for all enrolled participants. 
5.2.2 Protocol Deviations 
Protocol deviations will be determined with complying with all IRB-established 
procedures. Protocol deviations will be listed by participant and treatment for all enrolled 
participants. 
5.2.3 Participant Eligibility 
Eligibility status based upon meeting protocol entrance criteria will be listed for all 
enrolled participants. 
5.3 
Participant Demographics 
Demographics will be summarized using the safety population. The demographics 
consist of age, gender, race, ethnicity, height, body weight, and body mass index [BMI]. 
Individual demographics for the safety population will be listed by participant. 
5.4 
Medical History 
During screening, a complete medical history for the prior 1 year will be recorded for 
each participant. Medical history will include medical diagnoses, major surgical 
procedures, pregnancy, postpartum, and lactation history. 
Medical condition and/or significant medical history will be coded using Medical 
Dictionary for Regulatory Activities (MedDRA) Version 26.1 or later and listed by 
reported term, System Organ Class (SOC), and Preferred Term (PT). The number and 
percentage of participants will be summarized by SOC and PT for Safety Population. 


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Medical/surgical history will be listed by participant in the safety population. Listing 
will be sorted by descending total of ATC level and alphabetically in lower level. 
5.5 
Prior and Concomitant Medications 
All medications (including prescription and OTC medications) taken within 14 days 
before dosing (Day 1) with study medication throughout the study, and through 
poststudy visit will be coded using WHO Drug Enhanced Dictionary (September 2023 
version B3). Prior Medication and Concomitant Medication are defined as below: 
• Prior medications are defined as medications that stop prior to the first dose of 
study drug. 
• Concomitant medications are defined as medications that start within the 
period starting from the beginning of the screening period to the end of study 
(Day 5), and with end date no earlier than the first dose of study drug. 
Medications with missing or partially missing start or end dates will be handled per the 
conventions described in Appendix B. If it cannot be determined whether a medication 
was a prior medication due to missing or partial medication start or end dates, the 
medication will be considered concomitant. Concomitant medications will be 
summarized by Anatomical Therapeutic Class (ATC) level 1, ATC level 2, and Preferred 
Term. Prior and concomitant medications will be listed for each participant by treatment, 
Preferred Term, reported term, ATC level 1, ATC level 2, including the start and end 
dates, prior/concomitant flag, whether it is ongoing, dose, unit, frequency, route of 
administration and indication. The prohibited concomitant medications will be listed and 
tabulated in the same way as concomitant medications. Listing will be sorted by 
descending total of ATC level and alphabetically in lower level. 
5.6 
Treatment Exposure and Compliance 
The details of Ibrexafungerp treatment exposure and compliance, including actual dose 
(2 tablets x 150 mg or other), date time of dose, whether first treatment administered 
(yes/no), whether second treatment administered (yes/no) and reason for adjusted or 
missed dose will be listed by participant in the safety population. Percentage of 
compliance, number and percentage of participants with missing treatment or adjusted 
treatment will be summarized. The compliance will be calculated as total actual drug 
administered (mg) / total planned drug to be administered (mg) *100. 
5.7 
Pharmacokinetic Analysis 
5.7.1 Plasma and Breast milk Concentrations 
In displays of plasma and breast milk concentration summary statistics (and in PK 
analyses), all plasma concentrations below the limit of quantification (BLQ) of the assay 
will be treated as “0” if they occur before the first measurable or after the last measurable 
concentration, and will be set as missing for data points in between two measurable 
concentrations. If a sample is missing or the value is not reportable and is between two 
measurable concentrations, the value at that time point will be left blank for the analysis 
and reported as either Not Reportable (NR) or No Sample (NS). 
Individual participant plasma and breast milk ibrexafungerp concentrations, actual breast 


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milk and blood sampling dates and times, actual volume of breast milk collected at each 
time interval, actual dosing information (actual time and date of dosing, and actual dose 
taken) will be presented by participant in data listings. 
Ibrexafungerp concentrations in plasma and in breast milk measured over time will be 
displayed graphically for individual participants and for all participants in the PK 
population and will be summarized descriptively based on nominal times. Linear and 
semi-log plots of geometric mean (SD) and individual ibrexafungerp concentration 
versus time profiles will be displayed. These linear and semi log plots will be generated 
separately for time restricting up to 24 hrs and for complete study duration (0-108 hrs). 
For geometric mean concentration-time profile plots, the nominal PK sampling time will 
be used, for individual concentration-time profile plots, the actual PK sampling time will 
be used. 
The daily infant dosage (total drug present in milk and consumed by the infant per day) 
will be calculated as follows:  
• 
Calculated Daily Infant Dosage (mg/day) = Σ (total drug concentration in each 
milk collection multiplied by the expressed milk volume in each milk collection) 
The Milk Plasma Ratio (M/P) will be calculated. M/P = AUC0-24 milk/AUC0-24 plasma. 
The calculation of Milk plasma ratio (M/P) should be based on AUC and on multiple 
time points over 24 hours and not just a single point in time. 
Milk plasma ratio (M/P) = AUC0-24 milk /AUC0-24 plasma 
The relative infant dose (the percent of the weight-adjusted maternal dosage consumed 
in breast milk over 24 hours) will be calculated: 
• 
 Calculated Relative Infant Dose = Infant Dosage (mg/kg/day)/Maternal Dosage 
(mg/kg/day) multiplied by 100 
A table will be provided to include summary statistics on daily infant dosage, relative 
infant dose, and M/P based on AUC0-24. A listing of infant dose will be provided by time-
point. 
5.7.2 Pharmacokinetic Parameters 
Pharmacokinetic parameters will be derived for ibrexafungerp in plasma and in breast 
milk for participants in the PK population. Pharmacokinetic parameters are defined in 
Table 3. 
Table 3 : Pharmacokinetic Parameters 
 
Parameter 
Description 
Cmax 
Maximum concentration in plasma/breast milk 
Cmin 
Minimum concentration in breast milk 
Cav 
Average concentration in breast milk during the dosing 


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interval 
AUC0-24 
Area under the plasma/breast milk concentration-time 
curve from time zero to 24 hours 
M/P 
AUC0-24 milk /AUC0-24 plasma 
Tmax 
Time to reach maximum plasma/breast milk concentration 
AUC0-t 
Area under the plasma/breast milk concentration from 
time zero to tlast 
AUC0-inf 
Area under the plasma/breast milk concentration from 
time zero extrapolated to infinity 
AUC%extrapolated  
Percentage of AUC0-inf due to extrapolation from tlast to 
infinity. 
Kel or λz 
Elimination rate constant in plasma 
t½ 
Elimination half-life in plasma 
CL/F 
Clearance or apparent oral clearance in plasma 
Vd 
Apparent volume of distribution in plasma 
PK parameters will be presented by participant in data listings and will be summarized 
by participants in the PK population using descriptive statistics. 
The PK parameters of ibrexafungerp will include maximum concentration (Cmax) 
following first dose, area under the concentration-time curve (AUC0-24) time to 
maximum concentration (Tmax) after the first dose, and elimination half-life (t½) after the 
second dose that will be calculated by means of noncompartmental analysis (NCA) using 
Phoenix WinNonlin Version 8.4 (Certara USA, Inc.). AUC0-24 in milk to plasma ratio is 
of primary interest to the study objectives.  In addition, since blood samples and breast 
milk will be collected to 108 hours, AUC0-t and AUC0-inf will also be calculated and 
presented. 
Elimination rate constants and AUC determination will be based on the linear trapezoidal 
rule, and actual PK sample times will be used for the PK analyses. The t½, if calculated, 
will use at least 3 time points from the logarithmic terminal phase portion of the 
concentration time curve. Pharmacokinetic parameters derived with Kel such as t½ and 
AUC0-inf, will be listed but excluded from descriptive statistics if R2_adjusted < 0.8 in λz 
(Kel) estimation. 
For determination of AUC0-inf, if the percentage of extrapolated AUC is more than 20% 
of AUC0-inf from tlast to infinity, then individual AUC0-inf result will be listed but flagged 
as not reliable calculation. AUC0-inf for these flagged subjects will not be included in 
descriptive statistics table. 
The following plasma ibrexafungerp pharmacokinetic parameters will be calculated: 
area under the curve (AUC), peak plasma concentration (Cmax), time to peak plasma 
concentration (Tmax), plasma clearance or apparent oral clearance (CL/F), apparent 
volume of distribution (Vd), and terminal half-life (t1/2). 
The following PK parameters of ibrexafungerp in breast milk will be calculated: AUC 


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for the different collection periods, Cav based on AUC derived from collections at 
different time points above; total milk concentration data will be used to calculate Cmax, 
Cmin and Tmax. The Cav is calculated as follows. 
Cav = AUC0-24 / 24.h 
Plasma and breast milk PK parameters for individuals will be listed and summarized 
descriptively. 
Plasma and breast milk concentrations and PK parameters will be summarized using 
descriptive statistics. Summary statistics for PK parameters except for Tmax will be 
described by n, arithmetic mean (mean), arithmetic mean SD, arithmetic CV%, 
geometric mean, geometric SD, geometric CV%, min, median and max. For Tmax, 
summary statistics will be described by n, median, min and max. For t½, harmonic mean 
and pseudo SD will also be presented. CV% will be displayed in one decimal place. 
5.8 
Safety Analysis 
The safety and tolerability of ibrexafungerp will be assessed by the evaluation of adverse 
events, vital signs (blood pressure, heart rate, respiratory rate, and temperature), physical 
examination, 12-lead electrocardiogram (ECG), and laboratory safety (biochemistry, 
hematology, coagulation and urinalysis). 
Safety variables will be listed by all participants in the Safety Population. 
5.8.1 Adverse Events 
Adverse events (AEs) will be collected from the time of informed consent throughout 
the study, up through the poststudy visit. 
All AEs will be coded and classified according to MedDRA (Version 26.1 or later). The 
intensity of adverse events is judged by the Investigator as mild, moderate or severe; a 
causal relationship to study drug is judged by the Investigator as probably related, 
possibly related or unrelated; outcome of an adverse event is judged by the Investigator 
as recovered/resolved and not recovered/not resolved. Treatment-emergent adverse 
events (TEAEs) are defined as 1) AEs with an onset date and time after the first dose of 
study drug, or 2) any event already present that worsens in severity after exposure to the 
treatment. 
A serious adverse event (SAE) is an AE occurring during any study phase (ie, baseline, 
treatment, or follow-up), and at any dose of the investigational product that fulfils one 
or more of the following: 1) Results in death; 2) It is immediately life-threatening; 3) It 
requires in-participant hospitalization or prolongation of existing hospitalization; 4) It 
results in persistent or significant disability or incapacity or substantial disruption of the 
ability to conduct normal life functions; 5) Results in a congenital abnormality or birth 
defect; 6) It is an important medical event that may jeopardize the participant or may 
require medical intervention to prevent one of the outcomes listed above. The following 
are considered events of clinical interest (ECIs): 
• Overdose 


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• Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3 x ULN, 
confirmed by repeat laboratory test 
• Hypersensitivity Reactions 
Significant adverse events of particular clinical importance, other than SAEs and those 
AEs leading to discontinuation of the participant from the study, will be classified as 
other adverse events (OAEs). For each OAE, a narrative may be written and included in 
the Clinical Study Report. 
A summary table of AEs will be created containing: number of AEs, number of TEAEs, 
number of participants with TEAEs, number of participants with treatment-related 
TEAEs, number of serious TEAEs, number of participants with serious TEAE, number 
of participants with treatment-related serious TEAEs, number of serious AEs, number of 
participants with serious AEs, number of events of clinical interest (ECIs) and AEs 
leading to death, AEs leading to study discontinuation, AEs leading to treatment 
interruption, AEs leading to treatment discontinuation. 
All TEAEs will be summarized as the number and percentage of participants by SOC, 
PT. Missing or partially missing start and end dates for AEs will be handled according 
to the conventions detailed in Appendix A. For cases where ascertaining treatment-
emergence is unlikely, the event will be categorized as treatment-emergent AE. Separate 
summaries will be created by severity and by relationship to study drug. If the same AE 
(PT) is reported more than once for the same participant, it will only be counted once in 
the summary table. For summary tables by severity and relationship to study drug, if the 
same AE (PT) is reported more than once for the same participant, the highest severity 
grade (severe > moderate > mild) or the strongest relationship to treatment (probably 
related > possibly related > unrelated) will be counted in the summary table. All SAEs, 
AEs leading to study discontinuation and AEs leading to death will be summarized by 
SOC and PT. 
All AEs will be listed, and a flag will indicate if the AE is treatment emergent and a flag 
will indicate if the AE is unexpected adverse event. 
All serious AEs (SAEs) will be listed, and a flag will indicate if the SAE is treatment 
emergent. 
All adverse events leading to study discontinuation will be listed by participant. 
All adverse events leading to death will be listed by participant. All ECI will be listed by 
participant. 
5.8.2 Clinical Laboratory Assessments 
Hematology, coagulation, blood chemistry, urinalysis, alcohol, and urine drug screens, 
pregnancy screen, serology, and COVID-19 test will be performed as described in the 
schedule of assessment Table 1. 
Descriptive statistics for baseline value, actual value will be provided for clinical 
hematology, coagulation, chemistry laboratory tests and quantitative urinalysis including 
pH. The change from baseline value to Day 5 post study will be provided for hematology 


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and clinical chemistry. Baseline for clinical laboratory tests is defined as the last non-
missing assessment prior to administration of study drug. Conventional Units will be 
used for reporting the laboratory test results. Unscheduled lab visit assessments will be 
excluded from summary tables but will be provided in the listings. 
Values for any chemistry, hematology, coagulation and urinalysis values outside the 
clinical reference ranges, clinically significant or not will be flagged on the individual 
participant data listings. Laboratory test results will be assigned a low/normal/high 
(L/N/H) classification according to whether the value is below (low, L), within (normal, 
N), or above (high, H) the laboratory parameter’s reference range. Shifts from baseline 
(L/N/H) to Day 5 post study (L/N/H) will be presented for hematology and clinical 
chemistry only. 
Plots will be generated for laboratory parameters, including the absolute values and 
change from baseline values for hematology and clinical chemistry. 
Alcohol and urine drug screens, serology, COVID-19 test, pregnancy screen results will 
be listed by participant. 
5.8.3 Vital Signs Assessments 
Vital signs, including blood pressure (BP systolic and diastolic), heart rate, respiratory 
rate, and body temperature will be measured at the timepoints indicated in Table 1. 
All vital sign data including unscheduled records will be listed. Unscheduled records 
will be excluded from the summary statistics. Vital sign data including baseline value, 
actual value, and change from baseline to each post-baseline visit will be summarized 
by visit and timepoint. Abnormal or clinically significant (CS) vital signs will be flagged 
in the listings. 
5.8.4 Physical Examinations 
A standard physical examination will be performed at the timepoints indicated in 
Table 1. 
Physical examination results will be listed by participant in the safety population. 
5.8.5 Electrocardiogram (ECG) 
A safety 12-lead ECG will be obtained and evaluated by a physician for the presence of 
abnormalities at screening indicated in the Schedule of Assessments in Table 1. 
Participants should be resting in a semi-recumbent position for at least 10 minutes prior to 
having ECG readings obtained. ECG measurements will be single measurements. 
Electrocardiogram examination will be listed for each ECG parameter in the safety 
population, including datetime collection, testing result, abnormal or not, clinically 
significant or not, specification if clinically significant. 
5.9 
Interim Analysis 
An interim analysis will be conducted after five subjects have completed their 


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participation in the study. The analysis will involve the examination of pharmacokinetic 
and safety data and will comprise a full analysis as described in the SAP. The objective 
of the interim analysis is to determine whether the data from 5 participants is sufficient 
to address the objectives of the study and fulfill the post marketing requirement (PMR 
4069-2); if not the study shall continue to recruit up to 10 participants. 
The reporting analysis will involve descriptive statistical methods, including summaries, 
tabulations, graphs, or by-subject listings. Before initiating this analysis, the data for the 
study endpoints will undergo a thorough cleaning process, and the database will be soft-
locked. 
5.10 Statistical Programming and Deliverables 
All statistical analyses, tables and listings will be generated in SAS (version 9.3 or later) 
with appropriate documentation and programming validation. The table of contents of 
all tables, figures, and listings will be presented in a TFLs shell supplemental document. 


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5.11 Changes to the Planned Analysis 
Any deviation(s) of consequence from the SAP during the data analysis will be 
documented and justified in an amended SAP and/or in the final report or addressed in a 
separate document, as appropriate. 


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APPENDIX A. ADVERSE EVENTS DATE IMPUTATION 
 
AE Start Date 
AE Stop Date 
Algorithms 
Known 
Known 
NA 
Partial 
Impute stop date as the latest date possible (i.e., last day of month 
if day is missing or Dec 31 if day and month are missing). If the 
imputed stop date is later than the earlier date of data cutoff date 
and date of end of study, then use cutoff date or date of end of 
study, whichever is earlier, as the imputed AE stop date. 
Missing 
Impute stop date as follows: 
(1) if study is ongoing: data cutoff date 
(2) if study discontinued: date of end of study 
 
Partial 
Known 
Impute start date as follows: 
1. If day missing only: 
(1) if same year-month as that of the start date of study drug: first 
dose date of study drug or AE end date, whichever is earlier 
(2) if different year-month from that of the start date of study drug: 
first day of month 
2. If both month and day are missing: 
(1) if same year as that of the start date of study drug: first dose 
date of study drug or AE end date, whichever is earlier 
(2) if different year from that of the start date of study drug: January 
1st of the year 
Partial 
Impute start date as follows: 
1. If day missing only: 
(1) if same year-month as that of the start date of study drug: first 
dose date of study drug  
(2) if different year-month from that of the start date of study drug: 
first day of month 
2. If both month and day are missing: 
(1) if same year as that of the start date of study drug: first dose 
date of study drug  
(2) if different year from that of the start date of study drug: January 
1st of the year 
 
Impute stop date as the latest date possible (i.e., last day of month 
if day is missing or Dec 31 if day and month are missing). If the 
imputed stop date is later than the earlier date of data cutoff date 
and date of end of study, then use cutoff date or date of end of 
study, whichever is earlier, as the imputed AE stop date. 
Missing  
Impute start date as follows: 
1. If day missing only: 
(1) if same year-month as that of the start date of study drug: first 
dose date of study drug  
(2) if different year-month from that of the start date of study drug: 
first day of month 


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2. If both month and day are missing: 
(1) if same year as that of the start date of study drug: first dose 
date of study drug  
(2) if different year from that of the start date of study drug: January 
1st of the year 
 
Impute stop date as follows: 
(1) if study is ongoing: data cutoff date 
(2) if study discontinued: date of end of study 
Missing  
Known 
Impute start date as the first dose date of the study drug or AE end 
date, whichever is earlier. 
Partial 
Impute start date as the first dose date of the study drug. 
Impute stop date as the latest date possible (i.e., last day of month 
if day is missing or Dec 31 if day and month are missing). If the 
imputed stop date is later than the earlier date of data cutoff date 
and date of end of study, then use cutoff date or date of end of 
study, whichever is earlier, as the imputed AE stop date. 
Missing  
Impute start date as the first dose date of the study drug. 
Impute stop date as follows: 
(1) if study is ongoing: data cutoff date 
(2) if study discontinued: date of end of study 
 
 


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APPENDIX B. CONCOMITANT MEDICATIONS DATE IMPUTATION 
 
CM 
Start Date 
CM 
Stop Date 
 
Algorithms 
Known 
Known 
If stop date < start date of study drug: PRIOR 
If stop date ≥ start date of study drug, and start date ≤ end of study: 
CONCOMITANT 
If stop date ≥ start date of study drug and start date > end of study: 
POSTTREATMENT 
Partial 
Impute stop date as the latest date possible (i.e., last day of month if day 
missing or Dec 31 if day and month are missing), then: 
If stop date < start date of study drug: PRIOR 
If stop date ≥ start date of study drug, and start date ≤ end of study: 
CONCOMITANT 
If stop date ≥ start date of study drug, and start date > end of study: 
POSTTREATMENT 
Missing  
No PRIOR assignment if stop date is missing 
If start date ≤ end of study: CONCOMITANT 
If start date > end of study: POSTTREATMENT 
Partial 
Known 
Impute start date as the earliest date possible (i.e., first day of month if day 
missing or Jan 01 if day and month are missing), then: 
If stop date < start date of study drug: PRIOR 
If stop date ≥ start date of study drug and start date ≤ end of study: 
CONCOMITANT 
If stop date ≥ start date of study drug and start date > end of study: 
POSTTREATMENT 
Partial 
Impute start date as the earliest date possible (i.e., first day of month if day 
missing or Jan 01 if day and month are missing) and impute stop date as the 
latest date possible (i.e., last day of month if day is missing or Dec 31 if day 
and month are missing), then: 
If stop date < start date of study drug: PRIOR 
If stop date ≥ start date of study drug and start date ≤ end of study: 
CONCOMITANT 
If stop date ≥ start date of study drug and start date > end of study: 
POSTTREATMENT 
Missing 
 No PRIOR assignment if stop date is missing 
 
Impute start date as the earliest date possible (i.e., first day of month if day is 
missing or Jan 01 if day and month are missing), then: 
If start date ≤ end of study: CONCOMITANT 
 If start date > end of study: POSTTREATMENT  
CM 
Start Date 
CM 
Stop Date 
Algorithms 


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Missing  
Known 
 No POSTTREATMENT assignment if start date is missing 
 If stop date < start date of study drug: PRIOR  
 If stop date ≥ start date of study drug: CONCOMITANT  
Partial 
 No POSTTREATMENT assignment if start date is missing  
 Impute stop date as the latest date possible (i.e., last day of month if day 
missing or Dec 31 if day and month are missing), then: 
 If stop date < start date of study drug: PRIOR 
 If stop date ≥ start date of study drug: COMCOMITANT 
Missing  
 CONCOMITANT