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NCT Number: NCT07283263

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Anaheim, California, 92801, United States

Location status: Recruiting

Location contact

Peter Winkle, Site 0001

CONTACT

949-295-7809

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
  • Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
  • For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.

Exclusion criteria

  • Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
  • Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
  • Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
  • Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
  • Other protocol defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-985521

Drug

Specified dose on specified days.

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (AEs)

    Time frame: Up to approximately Day 40

  2. Number of participants with treatment-emergent serious adverse events (SAEs)

    Time frame: Up to approximately Day 40

  3. Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately Day 14

Secondary outcomes

  1. Maximum Concentration (Cmax) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  2. Time to Cmax (Tmax) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  3. Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  4. Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  5. Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  6. Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  7. Elimination Half-Life (T-HALF) of BMS-986521 in Plasma

    Time frame: Up to approximately Day 14

  8. Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)

    Time frame: Up to approximately Day 14

  9. Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521

    Time frame: Up to approximately Day 14

  10. Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521

    Time frame: Up to approximately Day 14

  11. Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521

    Time frame: Up to approximately Day 14

  12. Geometric Mean Cmax BMS-986521 under fed and fasted conditions

    Time frame: Up to approximately Day 11

    Cohort 3

  13. Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions

    Time frame: Up to approximately Day 11

    Cohort 3

  14. Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions

    Time frame: Up to approximately Day 11

    Cohort 3

  15. Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution

    Time frame: Up to approximately Day 11

    Part C

  16. Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution

    Time frame: Up to approximately Day 11

    Part C

  17. Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution

    Time frame: Up to approximately Day 11

    Part C

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain the NCT# and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jan 7, 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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