Study of PET Ligand 11C-BMS-986196 in Healthy Volunteers and MS patien
Research type
Research Study
Full title
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
IRAS ID
300762
Contact name
Paul Matthews
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2021-001986-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND:, 154386
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
The purpose of this study is to evaluate a new radioactive compound (radiotracer), 11C-BMS-986196, in healthy participants and participants with multiple sclerosis (MS). The use of 11C-BMS-986196 in this study is investigational (new). This is the first time it is being studied in humans.
The non-radioactive version of the radiotracer, BMS-986196, is an investigational drug being developed to treat MS. It has not been approved for the treatment of any disease. Data from this study will contribute to general research and the development of a new means to visualize brain inflammation, and are expected to facilitate development of therapies for progressive MS.
This study will involve up to 14 participants: 6 healthy participants in the first part and 8 MS participants in the second part. Each part of the study will last up to 6 weeks. The study will be conducted at one site in the United States (US) and one in the United Kingdom (UK). 6-7 participants will take part in the UK.
The study is sponsored by Bristol-Myers Squibb. It will assess the safety, tolerability and how participant’s bodies react after receiving the radiotracer. A camera in a positron emission tomography (PET) imaging scanner will record signals emitted by the radioactive tracer as it travels through the body to show how it is taken up (absorbed) and distributed in the body and brain.
Participants will undergo screening tests to check that it is safe for them to take part. Suitable participants will be given two doses of 11C-BMS-986196 over the course of 1 week and have PET scans immediately after. During the study, participants will undergo an MRI scan, PET CT/MRI scans, physical exams and study specific blood and urine samples.
The results of this study may help determine the possible use of this radiotracer in future studies.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0305
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion