A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)

This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of [14C]-Fosgonimeton.

Inclusion criteria

• 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.

Exclusion criteria

• 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)