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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497557
• Other study ID #: 20220024
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: April 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion:

• Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.

• Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.

• Females of nonchildbearing potential.

Exclusion:

• Inability to swallow oral medication or history of malabsorption syndrome.

• History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.

• Poor peripheral venous access.

• History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Omeprazole
Omeprazole will be administered as an oral capsule.
• Sotorasib
Sotorasib will be administered as an oral tablet.

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	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.	Day 1 to Day 11

External Links

•   AmgenTrials clinical trials website