Healthy Volunteers
Conditions
Keywords
Healthy volunteers, BMS-986521, Positron Emission Tomography, PET tracer
Brief summary
The purpose of this study is to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
Interventions
DRUGBMS-986521
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage occupancy of M4 receptor in the brain | Up to approximately 28 hours after last dose | Based on PET scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent AEs (TEAEs) | Up to Day 38 | — |
| Number of participants with treatment-emergent serious AEs (SAEs) | Up to Day 38 | — |
| Number of participants with treatment-emergent suicidal ideation and behavior | Up to Day 11 | Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
| Maximum Concentration (Cmax) of BMS-986521 in Plasma | Up to Day 11 | — |
| Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma | Up to Day 11 | — |
| Time to Cmax (Tmax) of BMS-986521 in Plasma | Up to Day 11 | — |
| Effective half-life (T-HALFeff) of BMS-986521 in Plasma | Up to Day 11 | — |
| Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F) | Up to Day 11 | — |
| Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521 | Up to Day 11 | — |
| Maximal effect (Emax) | Up to approximately 28 hours after last dose | Plasma concentrations of BMS-986521 versus M4 receptor occupancy |
| Half maximal effective concentration (EC50) | Up to approximately 28 hours after last dose | Plasma concentrations of BMS-986521 versus M4 receptor occupancy |
Countries
Belgium
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed