Status:
COMPLETED
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Lead Sponsor:
Amgen
Conditions:
Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 fast...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2022
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT05327491
Start Date
March 21 2022
End Date
July 17 2022
Last Update
December 14 2023
Active Locations (4)
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1
Labcorp Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States, 32117-5116
2
Miami Research Associates LLC - Main Campus / Late Phase
South Miami, Florida, United States, 33143-5026
3
Labcorp Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247-4989
4
Labcorp Clinical Research Unit - Madison
Madison, Wisconsin, United States, 53704-2526