CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Omeprazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05497557
NCT05497557Phase 1Completed

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

Amgen·interventional·Posted Aug 11, 2022·Updated Jan 19, 2024

In Brief

A Phase 1 clinical trial evaluating Omeprazole and Sotorasib for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedAug 11, 2022
Enrollment StartJul 14, 2022
Primary CompletionSep 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.9 years ago

Interventions

Omeprazoledrug

Omeprazole will be administered as an oral capsule.

Sotorasibdrug

Sotorasib will be administered as an oral tablet.