Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
- Registration Number
- NCT05581992
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male subjects or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
- Females of nonchildbearing potential.
Exclusion Criteria
- 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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMG 510 + Omeprazole AMG 510 Participants will receive AMG 510 on Day 1, daily doses of omeprazole on Days 4 to 8, and a single dose of both omeprazole and AMG 510 on Day 9. AMG 510 + Omeprazole Omeprazole Participants will receive AMG 510 on Day 1, daily doses of omeprazole on Days 4 to 8, and a single dose of both omeprazole and AMG 510 on Day 9.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of AMG 510 Day 1 and Day 9 Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 Day 1 and Day 9 AUC from time Zero to Infinity (AUCinf) of AMG 510 Day 1 and Day 9
- Secondary Outcome Measures
Name Time Method Number of Participants with an Adverse Event (AE) Day 1 to Day 11 Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc
🇺🇸Daytona Beach, Florida, United States