A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
Megadott ok: Business objectives have changed
Key facts
- Where
- London, Egyesült KirályságSee the site
- Phase
- 1. fázis
Where in Egyesült Királyság
- LondonLondon, Egyesült KirályságNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05064436
- Record updated
- 2025. április 24.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Benign MS defined as a baseline EDSS of 2.0 with MS diagnosis ≥ 10 years prior to Day 1. Spinal MS without clinical or radiological evidence of brain lesions. Any other combination of clinical and radiological data suggestive of an absence of inflammatory brain lesions; Any major surgery within 4 weeks of study treatment administration and/or any minor surgery within 2 weeks of tracer administration; For Part A only:; MS relapse within 14 days prior to Day 1. Participants with a MS relapse within 30 days prior to Day 1 must agree to have their second PET scan scheduled on Day 1 or Day 2; Other protocol-defined inclusion/exclusion criteria apply; Any significant acute or chronic medical illness; For Part B only:; Any significant acute or chronic medical illness (other than MS) posing a risk to the participant's safety or negatively affecting the ability to detect CNS PET signal; For Parts A \& B:.