A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05599828
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male subjects or female subjects, 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 + Famotidine AMG 510 Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11. AMG 510 + Omeprazole + Famotidine Omeprazole Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11. AMG 510 + Omeprazole + Famotidine Famotidine Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of AMG 510 Day 1, Day 4, Day 11 Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 Day 1, Day 4, Day 11 AUC from time Zero to Infinity (AUCinf) of AMG 510 Day 1, Day 4, Day 11
- Secondary Outcome Measures
Name Time Method Number of Participants with an Adverse Event (AE) Day 1 to Day 13 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
🇺🇸Dallas, Texas, United States