A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistributio
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
What it found
The trial ended early for another reason (see below).
Reason given: Business objectives have changed
What was tested
Treatment tested
- 11C-BMS-986196
Results by group
Number of Participants With Adverse Events Based on Severity.
From first visit up to 9 days post
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 1 Participants | 6 | |
| Part B | 1 Participants | 4 | |
| Part A | 1 Participants | 6 | |
| Part B | 2 Participants | 4 | |
| Part A | 0 Participants | 6 | |
| Part B | 0 Participants | 4 |
Number of Participants With Clinically Significant Changes in Electrocardiograms.
From first visit up to 9 days post
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 0 Participants | 6 | |
| Part B | 0 Participants | 4 |
Part A
Part B
Number of Participants With Clinically Significant Changes in Vital Signs.
From first visit up to 9 days post
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 0 Participants | 6 | |
| Part B | 0 Participants | 4 |
Part A
Part B
Number of Participants With Clinically Significant Changes in Laboratory Values.
From first visit up to 9 days post
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 0 Participants | 6 | |
| Part B | 0 Participants | 4 |
Part A
Part B
Number of Participants With Clinically Significant Changes in Phsyical Examinations.
From first visit up to 9 days post
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 2 Participants | 6 | |
| Part B | 3 Participants | 4 |
Part A
Part B
Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants
2 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 4.36 uSv/MBq | 0.57 (Standard Deviation) | 5 |
Image Acquisition Window After Tracer Administration
90 Mins
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part A | 90 Mins | 0–90 | 5 |
| Part B | 90 Mins | 0–90 | 4 |
Part A
Part B
Percentage of Participants With Test Repeatablity Based on SUV.
2 hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part B | 96.163 percentage | 3.621 (Standard Deviation) | 3 |
| Part B | 95.930 percentage | 3.427 (Standard Deviation) | 3 |
| Part B | 96.128 percentage | 3.67 (Standard Deviation) | 3 |
| Part B | 95.114 percentage | 3.557 (Standard Deviation) | 3 |
| Part B | 93.541 percentage | 6.164 (Standard Deviation) | 3 |
| Part B | 96.601 percentage | 3.675 (Standard Deviation) | 3 |
| Part B | 96.697 percentage | 3.571 (Standard Deviation) | 3 |
| Part B | 95.833 percentage | 2.957 (Standard Deviation) | 3 |
| Part B | 95.912 percentage | 3.893 (Standard Deviation) | 3 |
Percentage of Participants With Test Repeatablity Based on VT.
2 Hours
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part B | 88.339 percentage | 10.476 (Standard Deviation) | 4 |
| Part B | 73.396 percentage | 6.751 (Standard Deviation) | 4 |
| Part B | 85.514 percentage | 8.202 (Standard Deviation) | 4 |
| Part B | 88.486 percentage | 9.884 (Standard Deviation) | 4 |
| Part B | 85.167 percentage | 11.593 (Standard Deviation) | 4 |
| Part B | 88.114 percentage | 9.931 (Standard Deviation) | 4 |
| Part B | 87.262 percentage | 9.439 (Standard Deviation) | 4 |
| Part B | 83.233 percentage | 9.408 (Standard Deviation) | 4 |
| Part B | 79.804 percentage | 8.192 (Standard Deviation) | 4 |
Mean Standardized Uptake Value (SUV) in the Brain
On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part B | 0.773 g/mL | 0.101 (Standard Deviation) | 4 |
| Part A | 0.606 g/mL | 0.121 (Standard Deviation) | 5 |
| Part B | 0.713 g/mL | 0.122 (Standard Deviation) | 4 |
| Part B | 0.677 g/mL | 0.103 (Standard Deviation) | 4 |
| Part B | 0.623 g/mL | 0.132 (Standard Deviation) | 4 |
| Part B | 0.767 g/mL | 0.098 (Standard Deviation) | 4 |
| Part A | 0.590 g/mL | 0.108 (Standard Deviation) | 5 |
| Part B | 0.705 g/mL | 0.122 (Standard Deviation) | 4 |
| Part B | 0.817 g/mL | 0.099 (Standard Deviation) | 4 |
| Part A | 0.656 g/mL | 0.135 (Standard Deviation) | 5 |
| Part B | 0.755 g/mL | 0.126 (Standard Deviation) | 4 |
| Part B | 0.857 g/mL | 0.099 (Standard Deviation) | 4 |
| Part A | 0.672 g/mL | 0.134 (Standard Deviation) | 5 |
| Part B | 0.780 g/mL | 0.136 (Standard Deviation) | 4 |
| Part B | 0.763 g/mL | 0.101 (Standard Deviation) | 4 |
| Part A | 0.596 g/mL | 0.121 (Standard Deviation) | 5 |
| Part B | 0.705 g/mL | 0.122 (Standard Deviation) | 4 |
| Part B | 0.783 g/mL | 0.101 (Standard Deviation) | 4 |
| Part A | 0.606 g/mL | 0.118 (Standard Deviation) | 5 |
| Part B | 0.725 g/mL | 0.122 (Standard Deviation) | 4 |
| Part B | 0.797 g/mL | 0.155 (Standard Deviation) | 4 |
| Part A | 0.674 g/mL | 0.122 (Standard Deviation) | 5 |
| Part B | 0.745 g/mL | 0.159 (Standard Deviation) | 4 |
| Part B | 0.723 g/mL | 0.084 (Standard Deviation) | 4 |
| Part A | 0.550 g/mL | 0.096 (Standard Deviation) | 5 |
| Part B | 0.658 g/mL | 0.118 (Standard Deviation) | 4 |
Mean Volume of Distribution (VT) in the Brain
On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Part B | 2.378 mL/cm³ | 0.213 (Standard Deviation) | 4 |
| Part A | 2.498 mL/cm³ | 0.343 (Standard Deviation) | 5 |
| Part B | 2.505 mL/cm³ | 0.604 (Standard Deviation) | 4 |
| Part B | 2.805 mL/cm³ | 0.68 (Standard Deviation) | 4 |
| Part B | 3.095 mL/cm³ | 1.407 (Standard Deviation) | 4 |
| Part B | 2.608 mL/cm³ | 0.374 (Standard Deviation) | 4 |
| Part A | 2.645 mL/cm³ | 0.417 (Standard Deviation) | 5 |
| Part B | 2.660 mL/cm³ | 0.677 (Standard Deviation) | 4 |
| Part B | 2.535 mL/cm³ | 0.219 (Standard Deviation) | 4 |
| Part A | 2.715 mL/cm³ | 0.356 (Standard Deviation) | 5 |
| Part B | 2.638 mL/cm³ | 0.639 (Standard Deviation) | 4 |
| Part B | 2.883 mL/cm³ | 0.427 (Standard Deviation) | 4 |
| Part A | 2.953 mL/cm³ | 0.35 (Standard Deviation) | 5 |
| Part B | 2.903 mL/cm³ | 0.822 (Standard Deviation) | 4 |
| Part B | 2.340 mL/cm³ | 0.198 (Standard Deviation) | 4 |
| Part A | 2.453 mL/cm³ | 0.338 (Standard Deviation) | 5 |
| Part B | 2.470 mL/cm³ | 0.578 (Standard Deviation) | 4 |
| Part B | 2.540 mL/cm³ | 0.294 (Standard Deviation) | 4 |
| Part A | 2.645 mL/cm³ | 0.39 (Standard Deviation) | 5 |
| Part B | 2.680 mL/cm³ | 0.66 (Standard Deviation) | 4 |
| Part B | 2.445 mL/cm³ | 0.315 (Standard Deviation) | 4 |
| Part A | 2.645 mL/cm³ | 0.404 (Standard Deviation) | 5 |
| Part B | 2.710 mL/cm³ | 0.815 (Standard Deviation) | 4 |
| Part B | 2.790 mL/cm³ | 0.613 (Standard Deviation) | 4 |
| Part A | 2.675 mL/cm³ | 0.496 (Standard Deviation) | 5 |
| Part B | 2.665 mL/cm³ | 0.712 (Standard Deviation) | 4 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Part A | 6 | 0 (0.0%) | 0 |
| Part B | 4 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Adverse Events Based on Severity.
From first visit up to 9 days post
SafetyNumber of Participants With Clinically Significant Changes in Electrocardiograms.
From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Vital Signs.
From first visit up to 9 days post
SafetyNumber of Participants With Clinically Significant Changes in Laboratory Values.
From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Phsyical Examinations.
From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in C-SSRS.
Data Not Collected
Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants
2 hours
Image Acquisition Window After Tracer Administration
90 Mins
Percentage of Participants With Test Repeatablity Based on SUV.
2 hours
Percentage of Participants With Test Repeatablity Based on VT.
2 Hours
Percentage of Free Brain BTK Relative to Baseline
Data Not Collected
Mean Standardized Uptake Value (SUV) in the Brain
On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Mean Volume of Distribution (VT) in the Brain
On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Brain volume loss
Who could take part
MS (type not specified) · 18 to 55 · EDSS 0 to 6.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Dec 2021
Main results due
Dec 2023
Finished
Dec 2023
Results posted
Apr 2025