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
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called 11C-BMS-986196 by injecting it into healthy people and those with multiple sclerosis. Researchers want to see how the drug moves through the body and its effects on the brain and spinal cord.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for the treatment evaluated under different names, including 11C-BMS-986196?
The treatment BMS-986001, which may be related, was generally safe and well tolerated in healthy subjects, with no serious adverse events reported. However, BMS-986115, another related treatment, showed some side effects like diarrhea, nausea, and low phosphate levels in cancer patients, but was considered safe at certain doses.12345
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for adults with a BMI of 18-34 kg/m2 and weight ≥50 kg. Healthy participants are needed, as well as those diagnosed with MS per the McDonald criteria, having an EDSS score of 0-6.5. People can't join if they've had recent surgery or have benign MS, spinal MS without brain lesions, or any significant illness.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous administration of 11C-BMS-986196 and undergo PET-CT imaging
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 11C-BMS-986196
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania