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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

  • Clinicaltrials.gov identifier

    NCT05064436

  • Recruitment Status

    Not yet recruiting

  • First Posted

    October 1, 2021

  • Last update posted

    October 1, 2021

Save Trial

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

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 14 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official 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
  • Estimated Study Start Date: October 2021
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: March 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Part A - Healthy Participants
 Drug: 11C-BMS-986196
Specified dose on specified days
Experimental: Part B - Participants with MS
 Drug: 11C-BMS-986196
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 6 months ]
  • 2. Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 6 months ]
  • 3. Incidence of TEAEs by Maximum Severity [ Time Frame: Up to 6 months ]
  • 4. Incidence of Serious TEAEs [ Time Frame: Up to 6 months ]
  • 5. Incidence of TEAEs by System Organ Class [ Time Frame: Up to 6 months ]
  • 6. Incidence of TEAEs by Preferred Term [ Time Frame: Up to 6 months ]
  • 7. Radiation dosimetry calculated from PET-CT images in healthy participants [ Time Frame: At day 1 ]
  • 8. Image acquisition window after administration of 11C-BMS-986196 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 2nd 11C-BMS-986196 administration, Up to 6 days ]
  • Secondary Outcome Measures: 1. Calculated SUV in the brain [ Time Frame: After 2nd 11C-BMS-986196 administration, Up to 6 days ]
  • 2. Calculated VT in the brain [ Time Frame: After 2nd 11C-BMS-986196 administration, Up to 6 days ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, Michigan
Local Institution
Ann Arbor

United Kingdom
Local Institution
London

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05064436 History of Changes
  • Other Study ID Numbers: IM038-010, 2021-001986-19
  • First Posted: October 1, 2021 Key Record Dates
  • Last Update Posted: October 1, 2021
  • Last Verified: September 2021
  • 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
    Pathologic Processes
    Demyelinating Autoimmune Diseases, CNS
    Autoimmune Diseases of the Nervous System     Nervous System Diseases
    Demyelinating Diseases
    Autoimmune Diseases
    Immune System Diseases