A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

Key facts

Study ID

NCT05048784

Run by

Amgen

People needed

145

Starts

2021-08-16

Expected to finish

2022-02-18

Last updated by the study team

2023-09-18

Who can join

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

You may qualify if…

• 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.

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, 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.