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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05064436
• Collaborator: (none)
• Enrollment: 14
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 7.3
• Patients Per Site: 7
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (MS)	Drug: 11C-BMS-986196	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Dec 10, 2021
• Anticipated Primary Completion Date: Jul 20, 2022
• Anticipated Study Completion Date: Jul 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events (AEs) [Up to 6 months]

2. Incidence of Treatment-Emergent Adverse Events (TEAEs) [Up to 6 months]

3. Incidence of TEAEs by Maximum Severity [Up to 6 months]

4. Incidence of Serious TEAEs [Up to 6 months]

5. Incidence of TEAEs by System Organ Class [Up to 6 months]

6. Incidence of TEAEs by Preferred Term [Up to 6 months]

7. Radiation dosimetry calculated from PET-CT images in healthy participants [At day 1]

8. Image acquisition window after administration of 11C-BMS-986196 [After 2nd 11C-BMS-986196 administration, Up to 6 days]

9. 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]

10. 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 Outcome Measures

1. Calculated SUV in the brain [After 2nd 11C-BMS-986196 administration, Up to 6 days]

2. Calculated VT in the brain [After 2nd 11C-BMS-986196 administration, Up to 6 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Michigan	Ann Arbor	Michigan	United States	48109
2	Local Institution	London		United Kingdom	W6 8RF

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05064436
• Other Study ID Numbers: IM038-010; 2021-001986-19
• First Posted: Oct 1, 2021
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Multiple Sclerosis (MS); Healthy Participants; 11C-BMS-986196; PET tracer
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of May 31, 2022