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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2019-12-09

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment Sequence AB

Participants will be administered AMG 510 orally in the following order:

Period 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions.

Group Type EXPERIMENTAL

AMG 510

Intervention Type DRUG

Oral Tablet

Treatment Sequence BA

Participants will be administered AMG 510 orally in the following order:

Period 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions.

Group Type EXPERIMENTAL

AMG 510

Intervention Type DRUG

Oral Tablet

Interventions

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AMG 510

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Sotorasib

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes