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Completed

NCT Number: NCT06877702

A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
  • Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
  • Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.

Exclusion criteria

  • Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
  • Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
  • Participants with history of anaphylactic reactions are excluded.
  • Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
  • Participants with history of Gilbert's syndrome are excluded.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986460

Drug

Specified dose on specified days.

Primary outcomes

  1. Part 1: Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately Day 43

  2. Part 1: Number of Participants With Serious AEs (SAEs)

    Time frame: Up to approximately Day 43

  3. Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings

    Time frame: Up to approximately Day 21

  4. Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities

    Time frame: Up to approximately Day 21

  5. Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to approximately Day 21

  6. Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

    Time frame: Up to approximately Day 21

  7. Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460

    Time frame: Up to approximately Day 21

  8. Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460

    Time frame: Up to approximately Day 21

  9. Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460

    Time frame: Up to approximately Day 21

  10. Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460

    Time frame: Up to approximately Day 21

  11. Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax

    Time frame: Up to approximately Day 21

  12. Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)

    Time frame: Up to approximately Day 21

  13. Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)

    Time frame: Up to approximately Day 21

  14. Part 2: Number of Participants With AEs

    Time frame: Up to approximately Day 29

  15. Part 2: Number of Participants With SAEs

    Time frame: Up to approximately Day 29

  16. Part 2: Number of Participants With Clinically Significant PE Findings

    Time frame: Up to approximately Day 7

  17. Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities

    Time frame: Up to approximately Day 7

  18. Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to approximately Day 7

  19. Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings

    Time frame: Up to approximately Day 7

  20. Part 2: Cmax of BMS-986460

    Time frame: Up to approximately Day 7

  21. Part 2: Tmax of BMS-986460

    Time frame: Up to approximately Day 7

  22. Part 2: AUC [0-T] of BMS-986460

    Time frame: Up to approximately Day 7

  23. Part 2: AUC(INF) of BMS-986460

    Time frame: Up to approximately Day 7

Secondary outcomes

  1. Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax

    Time frame: Up to approximately Day 7

  2. Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)

    Time frame: Up to approximately Day 7

  3. Part 2: PK Linearity of BMS-986460 Based on AUC(INF)

    Time frame: Up to approximately Day 7

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Jan 20, 2026

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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