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

March 26, 2024 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Local Institution - 0002
  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - Healthy Participants
Drug: 11C-BMS-986196
Specified dose on specified days
Other Names:
  • BMS-986196
Experimental: Part B - Participants with MS
Drug: 11C-BMS-986196
Specified dose on specified days
Other Names:
  • BMS-986196

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Calculated SUV in the brain
Time Frame: After 2nd 11C-BMS-986196 administration, Up to 6 days
After 2nd 11C-BMS-986196 administration, Up to 6 days
Calculated VT in the brain
Time Frame: After 2nd 11C-BMS-986196 administration, Up to 6 days
After 2nd 11C-BMS-986196 administration, Up to 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

December 18, 2023

Study Completion (Actual)

December 18, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM038-010
  • 2021-001986-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis (MS)

Clinical Trials on 11C-BMS-986196

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe