A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
NCT05578859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2022-11-07
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
- DRUG
-
AMG 510
Single oral dose of AMG510.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-03-11
- Primary Completion
- 2020-03-24
- Completion
- 2020-03-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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