Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
