A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion 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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2020-06-14

Brief Summary

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The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion 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 in the following order:

Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water.

Group Type EXPERIMENTAL

AMG 510

Intervention Type DRUG

Tablets

Treatment Sequence BA

Participants will be administered AMG 510 in the following order:

Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets.

Group Type EXPERIMENTAL

AMG 510

Intervention Type DRUG

Tablets

Interventions

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AMG 510

Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects or healthy female between 18 and 55 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

* 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.
* Inability to swallow oral medication or history of malabsorption syndrome.
* Poor peripheral venous access.
* History of significant 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes