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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Multiple Sclerosis (MS)

Treatments

Drug: 11C-BMS-986196

Study type

Interventional

Funder types

Industry

Identifiers

NCT05064436

2021-001986-19 (EudraCT Number)

IM038-010

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

For Parts A & B:

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:

• 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
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