A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986521.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
Interventions
- Drug BMS-986521
Specified dose on specified days
Primary outcome measures
- Percentage occupancy of M4 receptor in the brain [Time frame: Up to approximately 28 hours after last dose]
Secondary outcome measures (11)
- 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]
- 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]
- Half maximal effective concentration (EC50) [Time frame: Up to approximately 28 hours after last dose]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven
Identifiers
NCT: NCT07655518 · CN014-0003 · EU CTR