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

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064436
• Other study ID #: IM038-010
• Secondary ID: 2021-001986-19
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

Drug:
• 11C-BMS-986196
Specified dose on specified days

Locations

Country	Name	City	State
United Kingdom	Local Institution - 0002	London
United States	Local Institution - 0001	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Up to 6 months
Primary	Incidence of Treatment-Emergent Adverse Events (TEAEs)		Up to 6 months
Primary	Incidence of TEAEs by Maximum Severity		Up to 6 months
Primary	Incidence of Serious TEAEs		Up to 6 months
Primary	Incidence of TEAEs by System Organ Class		Up to 6 months
Primary	Incidence of TEAEs by Preferred Term		Up to 6 months
Primary	Radiation dosimetry calculated from PET-CT images in healthy participants		At day 1
Primary	Image acquisition window after administration of 11C-BMS-986196		After 2nd 11C-BMS-986196 administration, Up to 6 days
Primary	Test-retest repeatability based on standardized uptake value (SUV) of CNS PET-MRI images in participants with MS		After 2nd 11C-BMS-986196 administration, Up to 6 days
Primary	Test-retest repeatability based on volume of distribution (VT) of CNS PET-MRI images in participants with MS		After 2nd 11C-BMS-986196 administration, Up to 6 days
Secondary	Calculated SUV in the brain		After 2nd 11C-BMS-986196 administration, Up to 6 days
Secondary	Calculated VT in the brain		After 2nd 11C-BMS-986196 administration, Up to 6 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting