Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.

Key facts

Study ID

NCT05581992

Run by

Amgen

People needed

14

Starts

2020-01-06

Expected to finish

2020-01-26

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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 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.

Where it is running

• Covance Clinical Research Unit, Inc — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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