Clincosm LogoSign in Get a demo

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05806359
Collaborator
(none)
32
Enrollment
1
Location
4
Arms
6.3
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants
Anticipated Study Start Date :
Mar 31, 2023
Anticipated Primary Completion Date :
Oct 9, 2023
Anticipated Study Completion Date :
Oct 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Japanese Cohort - Dose 1

Drug: Danicamtiv
Specified dose on specified days
Other Names:
  • BMS-986434
  • MYK-491

    • Drug: Placebo
    Specified dose on specified days
    Experimental: Japanese Cohort - Dose 2

    Drug: Danicamtiv
    Specified dose on specified days
    Other Names:
  • BMS-986434
  • MYK-491

    • Drug: Placebo
    Specified dose on specified days
    Experimental: Japanese Cohort - Dose 3

    Drug: Danicamtiv
    Specified dose on specified days
    Other Names:
  • BMS-986434
  • MYK-491

    • Drug: Placebo
    Specified dose on specified days
    Experimental: Caucasian Cohort - Dose 3

    Drug: Danicamtiv
    Specified dose on specified days
    Other Names:
  • BMS-986434
  • MYK-491

    • Drug: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [Day 1 up to Day 28]

    2. Number of Participants with Vital Sign Abnormalities [Day 1 up to Day 7]

    3. Number of Participants with Electrocardiogram (ECG) Abnormalities [Day 1 up to Day 7]

    4. Number of Participants with Physical Examination Abnormalities [Day 1 up to Day 7]

    5. Number of Participants with Clinical Laboratory Abnormalities [Day 1 up to Day 7]

    Secondary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) [Predose and at multiple timepoints (Day 1 up to Day 6) after dosing]

    2. Time of Maximum Observed Plasma Concentration (Tmax) [Predose and at multiple timepoints (Day 1 up to Day 6) after dosing]

    3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] [Predose and at multiple timepoints (Day 1 up to Day 6) after dosing]

    Eligibility Criteria

    Criteria

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

    • Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.

    • Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).

    • Caucasian participants must be of European or Latin American Caucasian descent.

    • A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.

    • Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.

    Exclusion Criteria:

    • Any acute or chronic medical illness.

    • Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.

    • History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

    Note: Other protocol-defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials Anaheim California United States 92801

    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:
    NCT05806359
    Other Study ID Numbers:
    • CV028-1001
    First Posted:
    Apr 10, 2023
    Last Update Posted:
    Apr 10, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Healthy
    Danicamtiv
    Japanese
    Caucasian

    Study Results

    No Results Posted as of Apr 10, 2023