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BMS-986533 for Healthy Participants

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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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety of a new treatment called BMS-986533 in healthy individuals. Researchers seek to understand how the body absorbs the drug and whether food or stomach acid affects it. They are also examining how BMS-986533 interacts with other medications. Individuals who are generally healthy, with a body mass index (BMI) between 18 and 32.44 and no significant health issues, may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I need to stop my current medications for this trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BMS-986533 is undergoing testing to determine its safety in healthy individuals. In these studies, participants received either a single dose or multiple doses of the treatment. So far, the treatment has been generally well-tolerated, with most participants experiencing no major issues. Early studies have not reported serious side effects. However, as this trial is in its initial stages, it primarily examines how the body processes the drug and its safety for humans. Consequently, information on long-term effects or rare side effects remains limited. Prospective participants should consult a healthcare provider for personalized advice before joining a trial.12345

Why are researchers excited about this trial's treatments?

BMS-986533 is unique because it targets a new pathway in the body that hasn't been addressed by existing treatments. Unlike traditional options that might focus on broad mechanisms, BMS-986533 specifically interacts with a novel receptor, potentially offering more precise therapeutic effects. Researchers are excited about this treatment because it could lead to more effective management of the condition with fewer side effects, paving the way for innovative approaches to health care.

What evidence suggests that this trial's treatments could be effective?

Research has shown that BMS-986533 is under study to assess its safety and pharmacokinetics. Solid evidence regarding its effectiveness for specific conditions is not yet available, as the focus remains on safety and the drug's movement through the body. Researchers are primarily examining how the body absorbs, distributes, and eliminates the drug. The intended effects of the drug are still unknown, as studies are in the early stages and involve healthy volunteers to ensure safety for further testing. Current findings emphasize safety rather than treatment potential. Participants in this trial will join one of the various treatment arms to evaluate these aspects.12467

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have significant medical conditions. People with certain health issues or on medications that could interfere with the study cannot participate.

Inclusion Criteria

Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg
I am female and cannot become pregnant, with proof of my reproductive status.
I am a sexually active male and agree to use contraception as instructed.

Exclusion Criteria

Other protocol defined inclusion/exclusion criteria applies
I have not had surgery that affects how my body absorbs or processes medicine.
I do not have any serious problems with my kidneys, liver, blood, or immune system.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple doses of BMS-986533 to evaluate safety, pharmacokinetics, and pharmacodynamics

Up to 26 days
Multiple visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label assessment

Assessment of food and pH effects on the relative bioavailability of BMS-986533

Concurrent with treatment phase

Drug-drug interaction study

Evaluation of P-gp and BCRP-mediated drug-drug interaction potential of BMS-986533

Concurrent with treatment phase

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986533

Trial Overview

The study tests a new drug called BMS-986533, given in single and multiple doses to healthy volunteers. It also looks at how food, stomach acidity, and other drugs (famotidine, rosuvastatin, dabigatran etexilate) affect its absorption and safety compared to placebo.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Arm DExperimental Treatment3 Interventions
Group II: Arm CExperimental Treatment2 Interventions
Group III: Arm BExperimental Treatment2 Interventions
Group IV: Arm AExperimental Treatment2 Interventions

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

Citations

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