ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
NCT05668429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-06-28
Summary
This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.
Conditions
- Fungal Disease
Interventions
- DRUG
-
Ibrexafungerp
carbon-14 (\[14\^C\])-Ibrexafungerp
Sponsors & Collaborators
-
Scynexis, Inc.
lead INDUSTRY
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
- 2022-12-14
- Primary Completion
- 2023-01-28
- Completion
- 2023-01-28
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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