NCT07655518RecruitingPhase 1
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
Bristol-Myers Squibb1 site in 1 country12 target enrollmentStarted: June 25, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
Study Overview
Brief Summary
The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
BMS-986521: Cohort 1
Experimental
Intervention: BMS-986521 (Drug)
BMS-986521: Cohort 2
Experimental
Intervention: BMS-986521 (Drug)
BMS-986521: Cohort 3
Experimental
Intervention: BMS-986521 (Drug)
Investigators
Study Sites (1)
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