BMS-986419 for Healthy Subjects

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cardiac disease, GI disease, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986419, to evaluate its safety in healthy individuals and its effects on the heart. Part 1 examines the drug’s safety and metabolism, while Part 2 assesses its impact on heart rhythms with multiple doses. Participants should be healthy, without major illnesses, and have a BMI between 18 and 30. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that BMS-986419 is likely to be safe for humans?

Research shows that BMS-986419 is under study to assess its safety and tolerability. Earlier studies examined the drug's mechanism in the body and its effects on heart rhythms. So far, no specific information about side effects in humans has been shared, which is typical for early studies. In this early phase, researchers are still gathering basic safety information. They closely monitor any side effects and how well participants tolerate the treatment. Joining this trial would contribute important data on the safety of BMS-986419. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BMS-986419 is unique because it introduces a novel mechanism of action that distinguishes it from typical treatments. Unlike standard treatments that might target symptoms or general pathways, BMS-986419 specifically targets a unique pathway that hasn't been explored before. This targeted approach could potentially offer more effective results with fewer side effects. Researchers are thrilled about BMS-986419 because it represents a promising shift in how we might address the condition, offering a fresh perspective and possibly paving the way for more precise therapies in the future.

What evidence suggests that BMS-986419 could be effective?

Research has shown that BMS-986419 is safe and well-tolerated in studies with healthy individuals. These studies reported no serious side effects, indicating a positive safety profile. In this trial, some participants will receive BMS-986419 to assess its effects on the heart's electrical activity, ensuring it does not cause heart problems. The study also examines the drug's absorption and processing in the body, known as pharmacokinetics, to help researchers understand its function. Although data on its effectiveness for specific conditions is not yet available, its safety in healthy volunteers is encouraging. ^{1 2 6 7 8}

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 individuals with a BMI between 18.0 and 30.0 kg/m^2. They must pass medical history reviews, physical exams, vital sign checks, ECGs, and lab tests to confirm their health status.

Inclusion Criteria

My BMI is between 18.0 and 30.0.

I am healthy based on recent medical exams and tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive BMS-986419 or placebo to assess safety, tolerability, and pharmacokinetics

3 weeks

Multiple visits (in-person)

Treatment Part 2

Participants receive multiple doses of BMS-986419 to evaluate effects on cardiac repolarization

2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986419

Trial Overview The study is testing BMS-986419's safety and how the body processes it (Part 1), as well as its effects on heart electrical activity after multiple doses (Part 2). Participants may receive the actual drug or placebos.

How Is the Trial Designed?

Group I: Part 2: Group 2b Experimental Treatment 3 Interventions

Group II: Part 2: Group 2a Experimental Treatment 3 Interventions

Group III: Part 2: Group 1 Experimental Treatment 3 Interventions

Group IV: Part 1: Administration of BMS-986419 Experimental Treatment 1 Intervention

Group V: Part 1: Administration of Placebo Placebo Group 1 Intervention

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

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

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

PD 0348292 was found to be well tolerated in healthy subjects during phase 1 studies, with only minor bleeding-related adverse events noted after multiple doses, indicating a favorable safety profile.

The drug demonstrated robust inhibition of thrombin generation in a concentration-dependent manner, suggesting its potential efficacy in managing coagulation, with pharmacokinetic properties supporting further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and pharmacodynamics of PD 0348292, an oral, direct factor Xa inhibitor, after single and multiple dosings in healthy subjects. Xuan, D., McBride, S., Wastall, P., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05932277

A Study to Assess the Effect of BMS-986419 on the Single ... The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-1bbfb

BMS-986419 for Healthy Subjects 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% ...

3. synapse.patsnap.com synapse.patsnap.com/drug/185df9ea12a1466fb41dc3d2cced9e26

BMS-986419 - Drug Targets, Indications, Patents A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 ...

4. bmsstudyconnect.com bmsstudyconnect.com/dk/en/clinical-trials/NCT05932277.html

A Study to Assess the Effect of BMS-986419 on the Single ... The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/584535

A Study to Investigate the Safety, Tolerability, and Drug ... The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-and-drug-levels-of-bms-986419-part-1-and-the-effe

A Study to Investigate the Safety, Tolerability, and Drug Levels ... The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple ...

7. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/35738283/bristol-myers-squibbs-new-study-on-bms-986419-a-potential-game-changer-in-cardiac-health/

Bristol-Myers Squibb's New Study on BMS-986419 ' The study aims to assess the safety, tolerability, and pharmacokinetics of BMS-986419, as well as its effects on cardiac repolarization, ...

8. tipranks.com tipranks.com/news/company-announcements/bristol-myers-squibbs-new-study-on-bms-986419-what-investors-should-know

Bristol-Myers Squibb's New Study on BMS-986419 ' The study aims to assess the safety, tolerability, and pharmacokinetics of BMS-986419, as well as its impact on cardiac repolarization in ...