Clinical trial NCT05064436: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis (MS)
Keywords: Multiple Sclerosis (MS)
Healthy Participants
11C-BMS-986196
PET tracer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events Based on Severity.
timeFrame: From first visit up to 9 days post
measure: Number of Participants With Clinically Significant Changes in Electrocardiograms.
timeFrame: From first visit up to 9 days post
measure: Number of Participants With Clinically Significant Changes in Vital Signs.
timeFrame: From first visit up to 9 days post
measure: Number of Participants With Clinically Significant Changes in Laboratory Values.
timeFrame: From first visit up to 9 days post
measure: Number of Participants With Clinically Significant Changes in Phsyical Examinations.
timeFrame: From first visit up to 9 days post
measure: Number of Participants With Clinically Significant Changes in C-SSRS.
timeFrame: Data Not Collected
measure: Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants
timeFrame: 2 hours
measure: Image Acquisition Window After Tracer Administration
timeFrame: 90 Mins
measure: Percentage of Participants With Test Repeatablity Based on SUV.
timeFrame: 2 hours
measure: Percentage of Participants With Test Repeatablity Based on VT.
timeFrame: 2 Hours
measure: Percentage of Free Brain BTK Relative to Baseline
timeFrame: Data Not Collected
measure: Mean Standardized Uptake Value (SUV) in the Brain
timeFrame: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
measure: Mean Volume of Distribution (VT) in the Brain
timeFrame: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Local Institution - 0001
state: Michigan
city: London
country: United Kingdom
facility: Local Institution - 0002
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: