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A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06027437
Collaborator
(none)
21
Enrollment
3
Arms
2.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants
Anticipated Study Start Date :
Sep 6, 2023
Anticipated Primary Completion Date :
Nov 9, 2023
Anticipated Study Completion Date :
Nov 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

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

    		•
    Experimental: Treatment B

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

    		•
    Experimental: Treatment C

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to day 16]

    2. Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to day 16]

    3. Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) [Up to day 16]

    Secondary Outcome Measures

    1. Time of maximum observed plasma concentration (Tmax) [Up to day 16]

    2. Terminal elimination half-life (T-HALF) [Up to day 16]

    3. Apparent total body clearance (CLT/F) [Up to day 16]

    4. Apparent volume of distribution (Vz/F) [Up to day 16]

    5. Number of participants with Adverse Events (AEs) [Up to day 43]

    6. Number of participants with Serious Adverse Events (SAEs) [Up to day 43]

    7. Number of participants with vital sign abnormalities [Up to day 16]

    8. Number of participants with Electrocardiogram (ECG) abnormalities [Up to day 16]

    9. Number of participants with Physical Examination (PE) abnormalities [Up to day 16]

    10. Number of participants with clinical laboratory abnormalities [Up to day 16]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive

    • Participants with resting heart rate ≥ 55 bpm

    • Seasonal allergies that do not require medication at the time of the study are acceptable

    Exclusion Criteria:

    • Any acute or chronic medical illness

    • Head injury, intracranial tumor, or aneurysm within 2 years prior to screening

    • History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion

    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:
    NCT06027437
    Other Study ID Numbers:
    • CV028-1012
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 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
    BMS-986434
    MYK-491
    Healthy
    Biological Availability
    Food Effect

    Study Results

    No Results Posted as of Sep 7, 2023