A Phase 1, Open-label, Multi-part Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution, and CNS Signal of the Positron Emission Tomography Ligand 11C-BMS-986196 in Healthy Participants After Intravenous Administration and to Evaluate the Safety, Tolerability, Kinetics, and CNS Signal Repeatability of 11C-BMS-986196 After Repeat Intravenous Administration in Participants With Multiple Sclerosis
The purpose of this study is to evaluate the safety, tolerability, kinetics, biodistribution and central nervous system signal of 11C-BMS-986196 after intravenous (IV) administration in healthy participants and after repeat IV administration in participants with multiple sclerosis.
⁃ For Parts A \& B:
• Body mass index (BMI) of 18 to 34 kg/m2, inclusive, and total body weight ≥ 50 kg
• Documentation of normal Allen's test result at Screening and on PET scanning days in the arm that will be used for arterial line placement
⁃ For Part A only:
⁃ • Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
⁃ For Part B only:
• Male or female participant diagnosed with MS according to the 2017 revisions of the McDonald diagnostic criteria
• Expanded Disability Status Scale (EDSS) score between 0 to 6.5, inclusive, at Screening