Healthy VolunteersPhase 1NCT07655518
A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
A Phase 1 study testing BMS-986521 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Belgium.
Trial summary
The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986521
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jun 2026to 27 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Koen Van Laere, Site 0001
About this study
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
The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986521
- Keywords
- Healthy volunteers, BMS-986521, Positron Emission Tomography, PET tracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986521Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986521: Cohort 1 | Experimental | Not described Receives: Drug: BMS-986521 |
| BMS-986521: Cohort 2 | Experimental | Not described Receives: Drug: BMS-986521 |
| BMS-986521: Cohort 3 | Experimental | Not described Receives: Drug: BMS-986521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage occupancy of M4 receptor in the brain
Based on PET scans
Measured: Up to approximately 28 hours after last dose
Secondary outcomes (11)
Number of participants with treatment-emergent AEs (TEAEs)
Measured: Up to Day 38
Number of participants with treatment-emergent serious AEs (SAEs)
Measured: Up to Day 38
Number of participants with treatment-emergent suicidal ideation and behavior
Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 11
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Measured: Up to Day 11
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma
Measured: Up to Day 11
Time to Cmax (Tmax) of BMS-986521 in Plasma
Measured: Up to Day 11
Effective half-life (T-HALFeff) of BMS-986521 in Plasma
Measured: Up to Day 11
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Measured: Up to Day 11
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Measured: Up to Day 11
Maximal effect (Emax)
Plasma concentrations of BMS-986521 versus M4 receptor occupancy
Measured: Up to approximately 28 hours after last dose
Half maximal effective concentration (EC50)
Plasma concentrations of BMS-986521 versus M4 receptor occupancy
Measured: Up to approximately 28 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start25 Jun 2026
- Primary completion27 Dec 2026 (estimated)
- Study completion27 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655518
- Sponsor's protocol ID
- CN014-0003
- Other IDs
- EU CTR
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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