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

Sponsor ID
20220024
Clinicaltrials.gov ID
NCT05497557
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
16
Additional Study Details

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
Status
Contact Us
Location
Labcorp Clinical Research Unit Inc.
Dallas, Texas, United States, 75247
Status
Recruiting