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A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

NCT ID: NCT05599828

Last Updated: 2024-12-12

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

2020-07-17

Study Completion Date

2020-09-13

Brief Summary

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The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.

Detailed Description

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Conditions

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Healthy Participants

Keywords

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Healthy Participants AMG 510 Famotidine Omeprazole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AMG 510 + Omeprazole + Famotidine

Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11.

Group Type EXPERIMENTAL

AMG 510

Intervention Type DRUG

Oral Tablet

Omeprazole

Intervention Type DRUG

Capsule

Famotidine

Intervention Type DRUG

Tablet

Interventions

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AMG 510

Oral Tablet

Intervention Type DRUG

Omeprazole

Capsule

Intervention Type DRUG

Famotidine

Tablet

Intervention Type DRUG

Other Intervention Names

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Sotorasib

Eligibility Criteria

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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 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

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Covance Clinical Research Unit, Inc

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20200199

Identifier Type: -

Identifier Source: org_study_id