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OpenTrials
Completed

NCT Number: NCT06577259

Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
  • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
  • Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.

Exclusion criteria

  • Any acute or chronic medical illness.
  • History of heart disease.
  • Prior exposure to BMS-986435.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986435

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 105 days

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

    Time frame: Up to 105 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to 105 days

Secondary outcomes

  1. Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]

    Time frame: Up to 105 days

  2. Time of maximum observed concentration [Tmax]

    Time frame: Up to 105 days

  3. Apparent terminal half-life [T-HALF]

    Time frame: Up to 105 days

  4. Incidence of adverse events (AEs)

    Time frame: Up to approximately 5 months

  5. Incidence of serious adverse events (SAEs)

    Time frame: Up to approximately 5 months

  6. Incidence of participants with vital sign abnormalities

    Time frame: Up to 105 days

  7. Incidence of participants with physical examinations abnormalities

    Time frame: Up to 105 days

  8. Incidence of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 105 days

  9. Incidence of participants with clinical laboratory abnormalities

    Time frame: Up to 105 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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