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

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.


Eligibility Criteria:
Key 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

Key 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