A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.

• 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/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 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.