A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

• Status: Not yet recruiting
• Trial end date: 2022-07-04
• Target enrollment: 0
• Participant gender: All

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 fasted conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• 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 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, 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.