NCT07283263

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
6mo left

Started Dec 2025

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Dec 2025Nov 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 23, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 2, 2025

Last Update Submit

January 5, 2026

Conditions

Healthy Volunteers

Keywords

Healthy VolunteersPharmacokineticsBMS-986521PlaceboDrug-food InteractionSingle Ascending Dose (SAD)Multiple Ascending Dose (MAD)ElderlyRelative Bioavailability

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (17)

  • 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

  • +12 more secondary outcomes

Study Arms (12)

Part A Cohort 1

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part A Cohort 2

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part A Cohort 3

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part A Cohort 4

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part A Cohort 5

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part A Cohort 6

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part B Cohort 7

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part B Cohort 8

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part B Cohort 9

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part B Cohort 10

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part B Cohort 11

EXPERIMENTAL
Drug: BMS-985521Other: Placebo

Part C

EXPERIMENTAL
Drug: BMS-985521

Interventions

BMS-985521DRUG

Specified dose on specified days.

Part A Cohort 1Part A Cohort 2Part A Cohort 3Part A Cohort 4Part A Cohort 5Part A Cohort 6Part B Cohort 10Part B Cohort 11Part B Cohort 7Part B Cohort 8Part B Cohort 9Part C
PlaceboOTHER

Specified dose on specified days

Part A Cohort 1Part A Cohort 2Part A Cohort 3Part A Cohort 4Part A Cohort 5Part A Cohort 6Part B Cohort 10Part B Cohort 11Part B Cohort 7Part B Cohort 8Part B Cohort 9

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Anaheim, California, 92801, United States

RECRUITING

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286Clinical.Trials@bms.com

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

December 23, 2025

Primary Completion (Estimated)

November 17, 2026

Study Completion (Estimated)

November 17, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

US(1)