BMS-986533 for Healthy Participants
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple doses of BMS-986533 to evaluate safety, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label assessment
Assessment of food and pH effects on the relative bioavailability of BMS-986533
Drug-drug interaction study
Evaluation of P-gp and BCRP-mediated drug-drug interaction potential of BMS-986533
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
Study Details | NCT07629999 | Single and Multiple Dose ...
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple ...
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ctv.veeva.com
ctv.veeva.com/study/single-and-multiple-dose-study-to-evaluate-safety-and-pharmacokinetics-of-bms-986533-in-healthy-partSingle and Multiple Dose Study to Evaluate Safety and ...
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple ...
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ISRCTN17572332: A first in human study in healthy ...
A first in human study in healthy volunteers to assess the safety, tolerability, and pharmacokinetics of BMS-986238 in healthy participants. Export as PDF ...
A Study to Evaluate the Safety, Tolerability, and Drug Levels of ...
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending ...
Trial ID CN014-0001 | NCT07283263 - BMS Clinical Trials
Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in ...
BMS-986465 Safety Study in Healthy Subjects
This trial aims to assess the safety and tolerability of a new treatment, BMS-986465, in healthy individuals. It also examines how food and other factors ...
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