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A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

NCT ID: NCT05327491

Last Updated: 2023-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2022-07-17

Brief Summary

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The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.

Detailed Description

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Conditions

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Healthy Participants

Keywords

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Sotorasib AMG 510

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Sequence ABC

Participants will be administered sotorasib orally in the following order:

Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2)

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Oral Tablet

Treatment Sequence BAC

Participants will be administered sotorasib orally in the following order:

Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2)

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Oral Tablet

Interventions

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Sotorasib

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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AMG 510

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/m\^2 (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, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants 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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Labcorp Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Site Status

Miami Research Associates LLC - Main Campus / Late Phase

South Miami, Florida, United States

Site Status

Labcorp Clinical Research Unit - Dallas

Dallas, Texas, United States

Site Status

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20210088

Identifier Type: -

Identifier Source: org_study_id