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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578859
• Other study ID #: 20190321
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2020
• Est. completion date: March 24, 2020

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AMG 510
Single oral dose of AMG510.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)		Day 1 to Day 14
Primary	AUC from time zero to the last quantifiable concentration (AUClast)		Day 1 to Day 14
Primary	Maximum observed concentration (Cmax)		Day 1 to Day 14
Primary	Time of Cmax (tmax)		Day 1 to Day 14
Primary	Apparent terminal elimination half-life (t1/2)		Day 1 to Day 14
Primary	Total clearance (AMG 510 only; CL/F)		Day 1 to Day 14
Primary	Volume of distribution (AMG 510 only; Vz/F)		Day 1 to Day 14
Primary	Plasma AMG 510 to total radioactivity ratio		Day 1 to Day 14
Primary	Whole blood to plasma total radioactivity ratio		Day 1 to Day 14
Primary	Amount (Aeu) of AMG510 excreted in urine		Day 1 to Day 14
Primary	Percentage (feu) of AMG510 excreted in urine		Day 1 to Day 14
Primary	Renal clearance (CLR) of AMG510		Day 1 to Day 14
Primary	Amount (Aef) of AMG510 excreted in feces		Day 1 to Day 14
Primary	Percentage (fef) of AMG510 excreted in feces		Day 1 to Day 14
Secondary	Metabolite profile of AMG 510		Day 1 to Day 14
Secondary	Identification of AMG 510 metabolites		Day 1 to Day 14
Secondary	Incidence of adverse events	Adverse events will be graded by severity. Laboratory abnormalities (hematology, clinical chemistry, and urinalysis test results) will be recorded as adverse events, in addition to abnormalities in vital signs and physical examinations.	Up to approximately 6 weeks
Secondary	QTc interval measured by 12-lead electrocardiogram (ECG)		Up to approximately 6 weeks

External Links

•   AmgenTrials clinical trials website