Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Location status: Recruiting
Location contact
Koen Van Laere, Site 0001
CONTACT
Recruiting
NCT Number: NCT07655518
A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by 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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
BMS-986521
DrugSpecified dose on specified days
Primary outcomes
-
Percentage occupancy of M4 receptor in the brain
Time frame: Up to approximately 28 hours after last dose
Based on PET scans
Secondary outcomes
-
Number of participants with treatment-emergent AEs (TEAEs)
Time frame: Up to Day 38
-
Number of participants with treatment-emergent serious AEs (SAEs)
Time frame: 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)
-
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Time frame: 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
-
Time to Cmax (Tmax) of BMS-986521 in Plasma
Time frame: Up to Day 11
-
Effective half-life (T-HALFeff) of BMS-986521 in Plasma
Time frame: Up to Day 11
-
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Time frame: Up to Day 11
-
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Time frame: 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
-
Half maximal effective concentration (EC50)
Time frame: Up to approximately 28 hours after last dose
Plasma concentrations of BMS-986521 versus M4 receptor occupancy
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 18, 2026
- Registry last updated
- Jul 10, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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