A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-02-18

Brief Summary

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The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

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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 ABC

Participants will be administered sotorasib dose A orally in the following order:

* Treatment A - as 3 tablets (test 1)
* Treatment B - as 8 tablets (reference)
* Treatment C - as 3 tablets (test 2)

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Oral tablet

Treatment Sequence BAC

Participants will be administered sotorasib dose A orally in the following order:

* Treatment B - as 8 tablets (reference)
* Treatment A - as 3 tablets (test 1)
* Treatment C - as 3 tablets (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 participant 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