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

• Conditions: Healthy Volunteers
• Interventions: Drug: Omeprazole; Drug: Sotorasib

• Registration Number: NCT05497557
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2023-04
• Results First Submitted: 2023-04-17
• Results First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Results First Posted: 2024-01-19
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omeprazole + Sotorasib	Omeprazole	-
Omeprazole + Sotorasib	Sotorasib	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Maximum Observed Plasma Concentration (Cmax) of Sotorasib	Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	Day 1 to Day 11	An adverse event is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an adverse event that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs were recorded as an adverse event.

Trial Locations

Locations (1)

Labcorp Clinical Research Unit Inc.; 🇺🇸 Dallas, Texas, United States