Clincosm LogoSign in Get a demo

A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05581758
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
25
Actual Duration (Days)
17
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.

Condition or Disease Intervention/Treatment Phase
  • Drug: AMG 510
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects
Actual Study Start Date :
Nov 14, 2019
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Sequence AB

Participants will be administered AMG 510 orally in the following order: Period 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions.

Drug: AMG 510
Oral Tablet
Other Names:
  • Sotorasib

    		•
    Experimental: Treatment Sequence BA

    Participants will be administered AMG 510 orally in the following order: Period 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions.

    Drug: AMG 510
    Oral Tablet
    Other Names:
  • Sotorasib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) of AMG 510 [Day 1 and Day 4]

    2. Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 [Day 1 and Day 4]

    3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510 [Day 1 and Day 4]

    Secondary Outcome Measures

    1. Number of Participants with an Adverse Event (AE) [Day 1 to Day 6]

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

    2. Cmax of AMG 510 Metabolite M24 [Day 1 and Day 4]

    3. AUClast of AMG 510 Metabolite M24 [Day 1 and Day 4]

    4. AUCinf of AMG 510 Metabolite M24 [Day 1 and Day 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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/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:
    NCT05581758
    Other Study ID Numbers:
    • 20190316
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Oct 17, 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
    Healthy Participants
    AMG 510
    Sotorasib

    Study Results

    No Results Posted as of Oct 17, 2022