Overview

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.