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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: BMS-985521

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain the NCT# and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
      • Contact: Peter Winkle, Site 0001; Phone Number: 949-295-7809

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Cohort 1	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part A Cohort 2	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part A Cohort 3	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part A Cohort 4	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part A Cohort 5	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part C	Drug: BMS-985521; Specified dose on specified days.
Experimental: Part A Cohort 6	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part B Cohort 7	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part B Cohort 8	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part B Cohort 9	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part B Cohort 10	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.
Experimental: Part B Cohort 11	Other: Placebo; Specified dose on specified days; Drug: BMS-985521; Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (AEs)	Up to approximately Day 40
Number of participants with treatment-emergent serious adverse events (SAEs)	Up to approximately Day 40
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to approximately Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax) of BMS-986521 in Plasma		Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma		Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma		Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma		Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma		Up to approximately Day 14
Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma		Up to approximately Day 14
Elimination Half-Life (T-HALF) of BMS-986521 in Plasma		Up to approximately Day 14
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)		Up to approximately Day 14
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521		Up to approximately Day 14
Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521		Up to approximately Day 14
Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521		Up to approximately Day 14
Geometric Mean Cmax BMS-986521 under fed and fasted conditions	Cohort 3	Up to approximately Day 11
Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions	Cohort 3	Up to approximately Day 11
Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions	Cohort 3	Up to approximately Day 11
Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution	Part C	Up to approximately Day 11
Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution	Part C	Up to approximately Day 11
Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution	Part C	Up to approximately Day 11

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): November 17, 2026
• Study Completion (Estimated): November 17, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Pharmacokinetics; Healthy Volunteers; Placebo; Relative Bioavailability; Single Ascending Dose (SAD); Multiple Ascending Dose (MAD); BMS-986521; Drug-food Interaction
• Other Study ID Numbers: CN014-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No