Study Complete
Sponsor ID
20200362

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

Sponsor ID
20200362
Clinicaltrials.gov ID
NCT04887064
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
20
Additional Study Details

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
Status
Contact Us
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