ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion (ADME) of Oral [14C]-Ibrexafungerp in Healthy Male Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of \[14C\]-ibrexafungerp following administration in healthy male subjects. Each subject will receive a single dose of \[14C\]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2019
CompletedFirst Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 14, 2020
August 1, 2020
6 months
March 4, 2020
August 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mass balance
Amount recovered expressed as a percentage of the dose administered
Day 20
Secondary Outcomes (2)
Routes and rates of elimination of [14C]-ibrexafungerp
Day 20
Number of subjects with treatment-emergent adverse events
Day 20
Study Arms (1)
Ibrexafungerp
EXPERIMENTALOral \[14C\]-Ibrexafungerp Single Dose
Interventions
Radio-labeled Ibrexafungerp, single dose.
Eligibility Criteria
You may qualify if:
- Healthy males
- Age 30 to 65 years of age at the time of signing informed consent
- Must be willing and able to participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
You may not qualify if:
- Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
- Current smokers
- Recent radiation exposure
- Subjects who have been enrolled in a 14C ADME study in the last 12 months
- An acute or chronic disease determined by the investigator to be clinically significant
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
- Evidence of renal impairment at screening
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scynexis, Inc.lead
- Inncelerexcollaborator
Study Sites (1)
Quotient Sciences
Nottingham, NG116Js, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nkechi Azie, MD
Scynexis, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 13, 2020
Study Start
December 5, 2019
Primary Completion
May 29, 2020
Study Completion
June 30, 2020
Last Updated
August 14, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share