M4 receptor occupancy with BMS-986521 in healthy adults
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
Run by Bristol-Myers Squibb · NCT07655518 · Data updated 2026-11-12
This study tests how well BMS-986521 occupies M4 muscarinic receptors in healthy adults using PET imaging.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | December 27, 2026 |
| Study ends | December 27, 2026 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07655518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults (both sexes, not able to bear children) with BMI 18–30 kg/m2 and weight at least 50 kg, with no clinically significant medical history.
✕Probably not a fit
Participants with any active medical condition or abnormal baseline assessments may not benefit from this research or may not receive the drug benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional study in healthy volunteers to measure receptor occupancy of the M4 muscarinic acetylcholine receptor by the drug BMS-986521. It uses PET imaging to quantify how much of the receptor is occupied at various doses. Participants must be healthy with no significant medical history and must not be of childbearing potential. The study is sponsored by Bristol-Myers Squibb and conducted at Universitaire Ziekenhuizen Leuven in Belgium. Protocol criteria exclude individuals with major CNS, cardiovascular, hepatic, renal, or other serious conditions or recent GI disease.
Why it matters
Potential benefit: If successful, the study could help define dosing and safety parameters for BMS-986521 affecting M4 receptors.
How similar studies have gone: Previous research using PET to assess receptor occupancy has shown informative dose–occupancy relationships for similar compounds.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.