Clinical trial NCT05578859: A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Healthy volunteers
AMG 510
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
timeFrame: Day 1 to Day 14
measure: AUC from time zero to the last quantifiable concentration (AUClast)
timeFrame: Day 1 to Day 14
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 to Day 14
measure: Time of Cmax (tmax)
timeFrame: Day 1 to Day 14
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: Day 1 to Day 14
measure: Total clearance (AMG 510 only; CL/F)
timeFrame: Day 1 to Day 14
measure: Volume of distribution (AMG 510 only; Vz/F)
timeFrame: Day 1 to Day 14
measure: Plasma AMG 510 to total radioactivity ratio
timeFrame: Day 1 to Day 14
measure: Whole blood to plasma total radioactivity ratio
timeFrame: Day 1 to Day 14
measure: Amount (Aeu) of AMG510 excreted in urine
timeFrame: Day 1 to Day 14
measure: Percentage (feu) of AMG510 excreted in urine
timeFrame: Day 1 to Day 14
measure: Renal clearance (CLR) of AMG510
timeFrame: Day 1 to Day 14
measure: Amount (Aef) of AMG510 excreted in feces
timeFrame: Day 1 to Day 14
measure: Percentage (fef) of AMG510 excreted in feces
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Metabolite profile of AMG 510
timeFrame: Day 1 to Day 14
measure: Identification of AMG 510 metabolites
timeFrame: Day 1 to Day 14
measure: Incidence of adverse events
timeFrame: Up to approximately 6 weeks
measure: QTc interval measured by 12-lead electrocardiogram (ECG)
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: