Study Complete
Sponsor ID
20210093
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Study Details
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
Protocol Summary
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Timeframe: 6 days
Area Under the Plasma Concentration‑time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib
Timeframe: 6 days
Area Under the Plasma Concentration‑time Curve from Time Zero to Infinity (AUCinf) of Sotorasib
Timeframe: 6 days
Secondary Outcome Measures
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: 9 days
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Timeframe: 3 days
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib
Timeframe: 3 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib
Timeframe: 3 days
Locations
Location
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Status
Recruiting
Location
Covance Clinical Research Unit
Dallas, Texas, United States, 75247
Status
Recruiting