Clincosm LogoSign in Get a demo

A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05686096
Collaborator
(none)
8
Enrollment
1
Arm
2.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants

Participants will be admitted to the study site for 3 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
Anticipated Study Start Date :
Jan 13, 2023
Anticipated Primary Completion Date :
Apr 5, 2023
Anticipated Study Completion Date :
Apr 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MYK-224

Drug: MYK-224
Specified dose on specified days
Other Names:
  • BMS-986435

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed concentration (Cmax) [Up to 45 days]

    2. Time to maximum observed concentration (Tmax) [Up to 45 days]

    3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) [Up to 45 days]

    Secondary Outcome Measures

    1. Metabolite profiling of BMS-986435 in plasma, urine, and feces [Up to 45 days]

    2. Number of participants with adverse events (AEs) [Up to 45 days]

    3. Number of participants with clinical laboratory abnormalities [Up to 45 days]

    4. Number of participants with vital sign abnormalities [Up to 45 days]

    5. Number of participants with electrocardiogram (ECG) abnormalities [Up to 45 days]

    6. Number of participants with physical examination abnormalities [Up to 45 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    • Body mass index between 18 and 32 kg/m^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.

    • Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.

    • Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.

    Key Exclusion Criteria:

    • Any acute or chronic medical illness.

    • History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).

    Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05686096
    Other Study ID Numbers:
    • CV029-012
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Absorption, Metabolism, and Excretion (ADME)
    MYK-224

    Study Results

    No Results Posted as of Jan 17, 2023