NCT05511558

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

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) Following a Single Subcutaneous Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: LeonaBio · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of \[14C\]-Fosgonimeton

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-Fosgonimeton	Carbon-14 Radiolabeled Fosgonimeton

Timeline

• Start date: 2022-07-13
• Primary completion: 2022-10-18
• Completion: 2022-10-26
• First posted: 2022-08-23
• Last updated: 2022-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study