Terminated/Withdrawn
Sponsor ID
20220098
A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants
Study Details
The primary objectives of the study are to compare the pharmacokinetics (PK) and demonstrate relative bioavailability of sotorasib administered as 4 oral tablets (test) to sotorasib administered as 8 oral tablets (reference) and to assess the effect of food on the PK of sotorasib administered as 4 oral tablets.
Protocol Summary
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) of Sotorasib
Timeframe: Approximately 9 days
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib
Timeframe: Approximately 9 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib
Timeframe: Approximately 9 days
Secondary Outcome Measures
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Approximately 9 days
Number of Participants who Experience a Serious Adverse Event (SAE)
Timeframe: Up to approximately 39 days
Locations
No locations found.