Study Complete
Sponsor ID
20220024
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered with an Acidic Beverage in Healthy Volunteers
Study Details
The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.
Protocol Summary
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Timeframe: Day 1 and Day 9
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib
Timeframe: Day 1 and Day 9
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Sotorasib
Timeframe: Day 1 and Day 9
Secondary Outcome Measures
Number of Participants with an Adverse Event (AE)
Timeframe: Day 1 to Day 11
Locations
Location
Labcorp Clinical Research Unit Inc.
Dallas, Texas, United States, 75247
Status
Recruiting