Study Complete
Sponsor ID
20200362
Pharmacokinetics of Sotorasib in Healthy Participants and Participants with Moderate or Severe Hepatic Impairment
Study Details
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.
Protocol Summary
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Timeframe: Day 1 to Day 8
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Sotorasib
Timeframe: Day 1 to Day 8
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib
Timeframe: Day 1 to Day 8
Secondary Outcome Measures
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 to Day 8
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Evaluations
Timeframe: Baseline to Day 8
Number of Participants with a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Timeframe: Baseline to Day 8
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Timeframe: Baseline to Day 8
Unbound Maximum Observed Plasma Concentration (Cmax,u) of Sotorasib
Timeframe: Day 1 to Day 8
Unbound Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast,u) of Sotorasib
Timeframe: Day 1 to Day 8
Unbound Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf,u) of Sotorasib
Timeframe: Day 1 to Day 8
Unbound Apparent Total Plasma Clearance (CLu/F) of Sotorasib
Timeframe: Day 1 to Day 8
Unbound Apparent Volume of Distribution During the Terminal Phase (Vz,u/F) of Sotorasib
Timeframe: Day 1 to Day 8
Locations
Location
Clinical Pharmacology Of Miami LLC
MIAMI, FL, United States, 33014
Status
Recruiting
Location
Orlando Clinical Research Center
Orlando, FL, United States, 32809
Status
Recruiting
Location
American Research Corporation
San Antonio, TX, United States, 78215
Status
Recruiting
Location
Pinnacle Clinical Research – San Antonio
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Recruiting