NCT05578859

A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects

A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of the study are: to characterize the primary route(s) of elimination of \[14C\]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of \[14C\]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of \[14C\]-AMG 510 in healthy male participants.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AMG 510	Single oral dose of AMG510.

Timeline

• Start date: 2020-03-11
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2022-10-13
• Last updated: 2022-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study