A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

Purpose

This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.

Condition

  • Healthy Volunteers

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive - Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments - Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment - Other protocol-defined Inclusion/

Exclusion Criteria

apply

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment B
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment C
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment D
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment E
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment F
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment G
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment H
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment I
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment J
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment K
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224
Experimental
Treatment L
  • Drug: BMS-986435
    Specified dose on specified days
    Other names:
    • MYK-224

Recruiting Locations

Quotient Miami
Miami, Florida 33126
Contact:
Juliet Vento, Site 0001

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com