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

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05497557
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
1.1
Anticipated Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Aug 4, 2022
Anticipated Primary Completion Date :
Sep 8, 2022
Anticipated Study Completion Date :
Sep 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Omeprazole + Sotorasib

Drug: Omeprazole
Omeprazole will be administered as an oral capsule.

Drug: Sotorasib
Sotorasib will be administered as an oral tablet.
Other Names:
  • AMG 510

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of Sotorasib [Day 1 and Day 9]

    2. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Sotorasib [Day 1 and Day 9]

    3. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Sotorasib [Day 1 and Day 9]

    Secondary Outcome Measures

    1. Number of Participants with an Adverse Event (AE) [Day 1 to Day 11]

      Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp Clinical Research Unit Inc. Dallas Texas United States 75247

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT05497557
    Other Study ID Numbers:
    • 20220024
    First Posted:
    Aug 11, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Healthy volunteers
    Sotorasib
    AMG 510
    Omeprazole
    Additional relevant MeSH terms:
    Omeprazole

    Study Results

    No Results Posted as of Aug 17, 2022