A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Amgen

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Omeprazole

Drug: Sotorasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05497557

20220024

Details and patient eligibility

About

The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.

Enrollment

16 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 participant safety or interfere with the study evaluation, procedures, or completion.