Status:
COMPLETED
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
Lead Sponsor:
Amgen
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 participan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04887064
Start Date
April 22 2021
End Date
March 9 2022
Last Update
April 19 2024
Active Locations (5)
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1
Orange County Research Center
Tustin, California, United States, 92780
2
Clinical Pharmacology Of Miami LLC
Miami, Florida, United States, 33014
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
4
American Research Corporation
San Antonio, Texas, United States, 78215