10 Participants Needed

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

Recruiting at 4 trial locations
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called 11C-BMS-986196 by injecting it into healthy people and those with multiple sclerosis. Researchers want to see how the drug moves through the body and its effects on the brain and spinal cord.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for the treatment evaluated under different names, including 11C-BMS-986196?

The treatment BMS-986001, which may be related, was generally safe and well tolerated in healthy subjects, with no serious adverse events reported. However, BMS-986115, another related treatment, showed some side effects like diarrhea, nausea, and low phosphate levels in cancer patients, but was considered safe at certain doses.12345

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with a BMI of 18-34 kg/m2 and weight ≥50 kg. Healthy participants are needed, as well as those diagnosed with MS per the McDonald criteria, having an EDSS score of 0-6.5. People can't join if they've had recent surgery or have benign MS, spinal MS without brain lesions, or any significant illness.

Inclusion Criteria

My disability level is moderate, allowing me some daily activity.
For Parts A & B: 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
I am healthy with no significant medical issues based on my history, physical exams, ECGs, and lab tests.
See 2 more

Exclusion Criteria

I have a serious ongoing health issue.
I have mild MS and was diagnosed over 10 years ago.
My MS is located in my spine without any signs of brain lesions.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous administration of 11C-BMS-986196 and undergo PET-CT imaging

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • 11C-BMS-986196
Trial OverviewThe study tests the safety and body distribution of a substance called 11C-BMS-986196 given through IV to healthy people and those with multiple sclerosis (MS). It looks at how the body processes this substance and its effects on the central nervous system.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part B - Participants with MSExperimental Treatment1 Intervention
Group II: Part A - Healthy ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

In a study involving 34 patients with advanced solid tumors, the maximum tolerated dose (MTD) of BMS-184476 was determined to be 60 mg/m2, with significant dose-limiting toxicities observed at higher doses, including severe neutropenia and diarrhea.
BMS-184476 demonstrated preliminary activity, with one patient showing a partial response and another a minor response, suggesting potential advantages over paclitaxel in terms of safety and pharmacokinetics, warranting further investigation.
Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel.Hidalgo, M., Aylesworth, C., Hammond, LA., et al.[2018]
BMS-986001 was found to be safe and well tolerated in a study involving 64 healthy male subjects, with no serious adverse events reported and only 14.6% experiencing mild adverse effects that were not dose-related.
The pharmacokinetics of BMS-986001 showed a linear dose-exposure relationship, indicating consistent absorption and effectiveness across various doses, regardless of whether it was taken with or without food.
Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects.Urata, Y., Paintsil, E., Cheng, YC., et al.[2014]

References

A multi-arm phase I dose escalating study of an oral NOTCH inhibitor BMS-986115 in patients with advanced solid tumours. [2020]
Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. [2018]
Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects. [2014]
Phase I and pharmacokinetic study of BMS-188797, a new taxane analog, administered on a weekly schedule in patients with advanced malignancies. [2007]
Evaluation of cerebral pharmacokinetics of the novel antidepressant drug, BMS-181101, by positron emission tomography. [2016]