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Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05598281
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
14
Actual Duration (Days)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 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, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects
Actual Study Start Date :
Nov 5, 2019
Actual Primary Completion Date :
Nov 19, 2019
Actual Study Completion Date :
Nov 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 510 + Digoxin

Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7.

Drug: AMG 510
Oral tablet
Other Names:
  • Sotorasib

    • Drug: Digoxin
    Oral tablet

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone [Day 1]

    2. Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone [Day 1]

    3. AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone [Day 1]

    4. Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510 [Day 7]

    5. AUClast of Digoxin Administered in Combination with AMG 510 [Day 7]

    6. AUCinf of Digoxin Administered in Combination with AMG 510 [Day 7]

    Secondary Outcome Measures

    1. Number of Participants with an Adverse Event (AE) [Day 1 to Day 13]

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

    2. Cmax of AMG 510 Administered in Combination with Digoxin [Day 7]

    3. AUClast of AMG 510 Administered in Combination with Digoxin [Day 7]

    4. AUCinf of AMG 510 Administered in Combination with Digoxin [Day 7]

    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 subjects, 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:
    NCT05598281
    Other Study ID Numbers:
    • 20190315
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Sep 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
    Digoxin
    Additional relevant MeSH terms:
    Digoxin

    Study Results

    No Results Posted as of Oct 28, 2022