ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
NCT04307082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2020-08-14
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.
Conditions
Interventions
- DRUG
-
[14C]-Ibrexafungerp
Radio-labeled Ibrexafungerp, single dose.
Sponsors & Collaborators
-
Inncelerex
collaborator UNKNOWN -
Scynexis, Inc.
lead INDUSTRY
Principal Investigators
-
Nkechi Azie, MD · Scynexis, Inc.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-12-05
- Primary Completion
- 2020-05-29
- Completion
- 2020-06-30
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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