A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

June 12, 2026 updated by: Bristol-Myers Squibb

A Phase 1, Open-label, Positron Emission Tomography (PET) Imaging Study to Evaluate M4 Muscarinic Acetylcholine Receptor Occupancy in the Central Nervous System Using [11C]MK-6884 PET Tracer Before and After Oral Administration of Multiple Doses of BMS-986521 in Healthy Adult Participants

The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain 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

  • Belgium
      • Leuven, Belgium, 3000
        • Local Institution - 0001
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must be healthy male and female (as assigned at birth) who are individuals not of childbearing potential (INOCBP) without clinically significant deviation from normal in medical history, PE, 12-lead ECG, and clinical laboratory assessments.
  • Participants must have a BMI of 18 to 30 kg/m^2, inclusive, and total body weight ≥ 50 kg.

Exclusion Criteria:

  • Participants must not have presence or history of any clinically relevant abnormality, condition, or disease-CNS, cardiovascular, renal, hepatic, hematologic, GI, endocrine, pulmonary, psychiatric, neurologic (eg, seizure disorder), or immunologic.
  • Participants must not have history of rhabdomyolysis.
  • Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
  • Other protocol defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986521: Cohort 1
Drug: BMS-986521
Specified dose on specified days
Experimental: BMS-986521: Cohort 2
Drug: BMS-986521
Specified dose on specified days
Experimental: BMS-986521: Cohort 3
Drug: BMS-986521
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage occupancy of M4 receptor in the brain
Time Frame: Up to approximately 28 hours after last dose
Based on PET scans
Up to approximately 28 hours after last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent AEs (TEAEs)
Time Frame: Up to Day 38
Up to Day 38
Number of participants with treatment-emergent serious AEs (SAEs)
Time Frame: Up to Day 38
Up to Day 38
Number of participants with treatment-emergent suicidal ideation and behavior
Time Frame: Up to Day 11
Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to Day 11
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Time Frame: Up to Day 11
Up to Day 11
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma
Time Frame: Up to Day 11
Up to Day 11
Time to Cmax (Tmax) of BMS-986521 in Plasma
Time Frame: Up to Day 11
Up to Day 11
Effective half-life (T-HALFeff) of BMS-986521 in Plasma
Time Frame: Up to Day 11
Up to Day 11
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Time Frame: Up to Day 11
Up to Day 11
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Time Frame: Up to Day 11
Up to Day 11
Maximal effect (Emax)
Time Frame: Up to approximately 28 hours after last dose
Plasma concentrations of BMS-986521 versus M4 receptor occupancy
Up to approximately 28 hours after last dose
Half maximal effective concentration (EC50)
Time Frame: Up to approximately 28 hours after last dose
Plasma concentrations of BMS-986521 versus M4 receptor occupancy
Up to approximately 28 hours after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 8, 2026

Primary Completion (Estimated)

December 27, 2026

Study Completion (Estimated)

December 27, 2026

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CN014-0003
  • EU CTR (Other Identifier: 2025-524564-38)

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.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

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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