NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

An Open-label Study to Evaluate the Impact of Omeprazole, A Proton Pump Inhibitor, on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole will be administered as an oral capsule.
DRUG	Sotorasib	Sotorasib will be administered as an oral tablet.

Timeline

• Start date: 2022-07-14
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2022-08-11
• Last updated: 2024-01-19
• Results posted: 2024-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study