A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of \[14C\]-Fosgonimeton
Key facts
- Study ID
- NCT05511558
- Run by
- LeonaBio
- People needed
- 8
- Starts
- 2022-07-13
- Expected to finish
- 2022-10-26
- Last updated by the study team
- 2022-12-22
Who can join
Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Males, of any race, between 18 and 60 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by the investigator's discretion
- Subjects and their partners will agree to use contraception during their participation
- History of a minimum of 1 bowel movement per day.
You may not qualify if…
- Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
- Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
- Poor peripheral venous access.
- Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)
Where it is running
- Labcorp Clinical Research Unit — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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