Covance Clinical Research Unit, Inc
Madison, Wisconsin, 53704, United States
NCT Number: NCT05578859
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral dose of AMG510.
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Day 1 to Day 14
Time frame: Up to approximately 6 weeks
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.
Time frame: Up to approximately 6 weeks
Amgen
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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