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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

Primary Purpose

Multiple Sclerosis (MS)

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

11C-BMS-986196

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis (MS) focused on measuring Multiple Sclerosis (MS), Healthy Participants, 11C-BMS-986196, PET tracer

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

University Of MichiganRecruiting
Local Institution - 0002Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A - Healthy Participants

Part B - Participants with MS

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AEs)

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Incidence of TEAEs by Maximum Severity

Incidence of Serious TEAEs

Incidence of TEAEs by System Organ Class

Incidence of TEAEs by Preferred Term

Radiation dosimetry calculated from PET-CT images in healthy participants

Image acquisition window after administration of 11C-BMS-986196

Test-retest repeatability based on standardized uptake value (SUV) of CNS PET-MRI images in participants with MS

Test-retest repeatability based on volume of distribution (VT) of CNS PET-MRI images in participants with MS

Secondary Outcome Measures

Calculated SUV in the brain

Calculated VT in the brain

Full Information

NCT ID

NCT05064436

First Posted

September 22, 2021

Last Updated

April 11, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT05064436

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

July 23, 2023 (Anticipated)

Study Completion Date

July 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis (MS)

Keywords

Multiple Sclerosis (MS), Healthy Participants, 11C-BMS-986196, PET tracer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A - Healthy Participants

Arm Type

Experimental

Arm Title

Part B - Participants with MS

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

11C-BMS-986196

Other Intervention Name(s)

BMS-986196

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events (AEs)

Time Frame

Up to 6 months

Title

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time Frame

Up to 6 months

Title

Incidence of TEAEs by Maximum Severity

Time Frame

Up to 6 months

Title

Incidence of Serious TEAEs

Time Frame

Up to 6 months

Title

Incidence of TEAEs by System Organ Class

Time Frame

Up to 6 months

Title

Incidence of TEAEs by Preferred Term

Time Frame

Up to 6 months

Title

Radiation dosimetry calculated from PET-CT images in healthy participants

Time Frame

At day 1

Title

Image acquisition window after administration of 11C-BMS-986196

Time Frame