Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2022-03-09

Brief Summary

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The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal Hepatic Function

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Sotorasib will be administered as an oral tablet.

Moderate Hepatic Impairment

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Sotorasib will be administered as an oral tablet.

Severe Hepatic Impairment

Group Type EXPERIMENTAL

Sotorasib

Intervention Type DRUG

Sotorasib will be administered as an oral tablet.

Interventions

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Sotorasib

Sotorasib will be administered as an oral tablet.

Intervention Type DRUG

Other Intervention Names

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AMG 510

Eligibility Criteria

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Inclusion Criteria

All Participants

* Participant has provided informed consent before initiation of any study-specific activities/procedures
* Participants between 18 and 70 years of age
* Body mass index between 18 and 38 kg/m\^2
* Females of nonchildbearing potential defined as permanently sterile or postmenopausal

Participants with Normal Hepatic Function

* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations

Participants with Hepatic Impairment

* Child-Pugh B or C classification with clinical laboratory values and clinical examination findings
* Documented medical history of chronic liver disease

Exclusion Criteria

All Participants

* Female participants with a positive pregnancy test at Screening or Check-in
* Male participants with a pregnant partner or partner planning to become pregnant who are unwilling to practice abstinence or use a condom for 7 days after dosing
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* Participant has received a dose of an investigational drug (new chemical entity) within the past 30 days or 5 half-lives, whichever is longer, prior to Check-in
* Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer)
* All herbal medicines vitamins, and supplements consumed by the subject within the 30 days prior to enrollment
* Alcohol consumption from 48 hours prior to Check-in
* Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Check-in
* Positive human immunodeficiency virus test at Screening

Participants with Normal Hepatic Function

* Positive hepatitis B or hepatitis C panel at Screening. Subjects whose results are compatible with prior immunity (vaccination or prior infection) may be included
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN) at Screening or Check-in
* Total bilirubin levels \> ULN at Screening or Check-in
* A QT interval corrected for heart rate based on the Fridericia correction (QTcF) interval \> 450 msec in male subjects or \> 470 msec in female subjects or history/evidence of long QT syndrome at Screening or Check-in, confirmed by calculating the mean of the original value and 2 repeats

Participants with Hepatic Impairment

* Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee)
* A QTcF interval \> 470 msec in male subjects or \> 480 msec in female subjects at Screening or Check-in, confirmed by calculating the mean of the original value and 2 repeats
* Use of a new medication, or a change in dose, for the treatment, or worsening of, hepatic encephalopathy within 30 days prior to Check-in
* Presence of a portosystemic shunt
* Evidence of severe ascites

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes