A Positron Emission Tomography Study to Assess the Occupa... | NCT07655518

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

NCT07655518

Sponsor

Bristol-Myers Squibb

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

BMS-986521

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EU CTR	Other Identifier	2025-524564-38

Official Title

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

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2026Actual

Primary Completion Date

Dec 27, 2026Estimated

Completion Date

Dec 27, 2026Estimated

First Submitted Date

May 29, 2026

First Submission Date that Met QC Criteria

Jun 12, 2026

First Posted Date

Jun 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BMS-986521: Cohort 1	Experimental	Drug: BMS-986521
BMS-986521: Cohort 2	Experimental	Drug: BMS-986521
BMS-986521: Cohort 3	Experimental	Drug: BMS-986521

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986521	Drug	Specified dose on specified days	BMS-986521: Cohort 1 BMS-986521: Cohort 2 BMS-986521: Cohort 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-emergent AEs (TEAEs)		Up to Day 38
Number of participants with treatment-emergent serious AEs (SAEs)		Up to Day 38
Number of participants with treatment-emergent suicidal ideation and behavior

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com	Contact	855-907-3286		Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.	Contact

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Recruiting	Leuven		3000	Belgium

Label	URL
BMS Clinical Trial Information	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

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