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

NCT ID: NCT05578859

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2020-03-24

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AMG510

Each participant will receive a single oral dose of AMG510 on Day 1 after an overnight fast.

Group Type: EXPERIMENTAL

AMG 510

Intervention Type: DRUG

Single oral dose of AMG510.

Interventions

AMG 510

Single oral dose of AMG510.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male participants between 18 and 55 years of age (inclusive) at the time of Screening.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations as assessed by the Investigator (or designee).
• Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
• History of a minimum of 1 bowel movement per day.

Exclusion Criteria

• History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
• Inability to swallow oral medication or history of malabsorption syndrome.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
• Poor peripheral venous access.
• History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
• Participant has received a dose of an investigational drug (new chemical entity) within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.
• Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
• Participants who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR)-recommended levels considered safe, per US Title 21 CFR 361.1: less than 5000 mrem whole body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Covance Clinical Research Unit, Inc

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20190321

Identifier Type: -

Identifier Source: org_study_id