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

Phase 1 Completed 16 enrolled Amgen

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2022-07-14
Primary completion: 2022-09-08
Completion: 2022-09-08

Publications

Cardona P, Strydom N, Houk B. Impact of Acid-Reducing Agents on Sotorasib Pharmacokinetics and Potential Mitigation of the Impact by Coadministration With an Acidic Beverage. Clin Pharmacol Drug Dev. 2025 Feb;14(2):167-176. doi: 10.1002/cpdd.1489. Epub 2024 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omeprazole	Other / unclassified	40 mg	Oral
Subject	Sotorasib	Small molecule	960 mg	Oral

Indications

No indication recorded.