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.

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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Safety Population: All participants who received sotorasib and had at least 1 postdose safety assessment.

Day 1 to Day 8

All participants who received 960 mg single oral dose of sotorasib, including participants with no hepatic impairment, moderate hepatic impairment and severe hepatic impairment.