Breast Cancer Clinical Trial

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Summary

A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.

View Eligibility Criteria

Eligibility Criteria

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, including history of myolysis, 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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT05045638

Recruitment Status:

Completed

Sponsor:

Amgen

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There is 1 Location for this study

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Covance Clinical Research Unit - Daytona Beach
Daytona Beach Florida, 32117, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

13

Study ID:

NCT05045638

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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