A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
Key facts
- Study ID
- NCT05327491
- Run by
- Amgen
- People needed
- 146
- Starts
- 2022-03-21
- Expected to finish
- 2022-07-17
- Last updated by the study team
- 2023-12-14
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
- Females of nonchildbearing potential.
You may not qualify if…
- Inability to swallow oral medication or history of malabsorption syndrome.
- History of 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 or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants safety or interfere with the study evaluation, procedures, or completion.
Where it is running
- Labcorp Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States
- Miami Research Associates LLC - Main Campus / Late Phase — South Miami, Florida, United States
- Labcorp Clinical Research Unit - Dallas — Dallas, Texas, United States
- Labcorp Clinical Research Unit - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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