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Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05581992
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
20
Actual Duration (Days)
21.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual 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 Drug-drug Interaction Effect of Omeprazole, a Proton-pump Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Actual Study Start Date :
Jan 6, 2020
Actual Primary Completion Date :
Jan 26, 2020
Actual Study Completion Date :
Jan 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 510 + Omeprazole

Participants will receive AMG 510 on Day 1, daily doses of omeprazole on Days 4 to 8, and a single dose of both omeprazole and AMG 510 on Day 9.

Drug: AMG 510
Oral Tablet
Other Names:
  • Sotorasib

    • Drug: Omeprazole
    Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of AMG 510 [Day 1 and Day 9]

    2. Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 [Day 1 and Day 9]

    3. AUC from time Zero to Infinity (AUCinf) of AMG 510 [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 Criteria:

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

    • Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.

    • Females of nonchildbearing potential.

    Exclusion Criteria:

    • 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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Unit, Inc Daytona Beach Florida United States 32117

    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:
    NCT05581992
    Other Study ID Numbers:
    • 20190320
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Oct 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
    AMG 510
    Healthy Participants
    Omeprazole
    Additional relevant MeSH terms:
    Omeprazole

    Study Results

    No Results Posted as of Oct 17, 2022