BMS-986435 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well different tablet versions of the experimental treatment BMS-986435 are absorbed in the body. This early-phase study focuses on healthy adults to understand how the body processes the medication. Participants should be in good health, without major health issues, and have normal heart function. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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 without any acute or chronic medical illness, it's likely that you should not be on any regular medications.

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

Research has shown that BMS-986435, also known as MYK-224, is under study to assess its safety and tolerability. This drug is primarily being tested for heart conditions such as heart failure with preserved ejection fraction (HFpEF). So far, these studies have not identified any serious safety issues.

The drug appears to be well-tolerated, with few adverse side effects reported. As this trial is in an early stage, the primary focus is on ensuring the drug does not cause harm. It is important to note that further studies are necessary to confirm these findings. However, initial data suggests that BMS-986435 is safe for use in controlled settings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-986435 because it offers a novel approach to drug delivery that could enhance bioavailability, meaning the body might absorb it more effectively compared to existing treatments. Unlike standard treatments that may utilize older delivery methods, BMS-986435 formulations are being tested to see if they can provide more efficient dosing with potentially fewer side effects. This could lead to improved patient outcomes and a more convenient treatment experience.

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

Research has shown that BMS-986435 is under study for its potential to treat heart conditions, particularly heart failure with preserved ejection fraction (HFpEF). Early results suggest it might improve heart function by affecting processes involved in heart muscle contraction. The trial includes different treatment arms: Treatment A (BMS-986435 Reference Dose 1), Treatment B (BMS-986435 Test Dose 1), and Treatment C (BMS-986435 Test Dose 2). These arms evaluate patient tolerance and the drug's overall safety. While detailed efficacy information is still being gathered, ongoing research offers promise for those with heart-related issues. ^{1 2 3 4 6}

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 weigh at least 45 kg with a BMI between 18 and 32. Participants must have no significant health issues as confirmed by medical history, physical exams, heart tests (ECG), lab assessments, and must have normal heart pumping function.

Inclusion Criteria

My weight is at least 45 kg and my BMI is between 18 and 32.

I am generally healthy based on recent medical exams.

My heart's pumping ability is good and I have no major heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of BMS-986435 in a three-way crossover design to assess relative bioavailability

3 weeks

3 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-986435

Trial Overview The study is testing the absorption of different tablet forms of BMS-986435 in men and women to see how well they work and if there are any differences between them.

How Is the Trial Designed?

Group I: Treatment C: BMS-986435 Test Dose 2 Experimental Treatment 1 Intervention

Group II: Treatment B: BMS-986435 Test Dose 1 Experimental Treatment 1 Intervention

Group III: Treatment A: BMS-986435 Reference Dose 1 Active Control 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06122779

NCT06122779 | Study to Evaluate Safety, Tolerability and ... The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart ...

2. bmsstudyconnect.com bmsstudyconnect.com/mx/en/clinical-trials/NCT06122779.html

study connect - BMS Clinical Trials Study to evaluate safety, tolerability and drug levels of BMS-986435/MYK-224 in participants with heart failure with preserved ejection fraction (HFpEF).

3. clinicaltrials.eu clinicaltrials.eu/inn/bms-986435/

BMS-986435: A Promising New Drug in Clinical Trials These trials aim to evaluate its safety, effectiveness, and potential benefits for patients with heart conditions, particularly those with Heart Failure with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05556343

NCT05556343 | A Study to Evaluate the Efficacy, Safety ... The purpose of this study is to characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants ...

5. trialx.com trialx.com/clinical-trials/listings/216933/study-to-evaluate-safety-tolerability-and-drug-levels-of-bms-986435myk-224-in-participants-with-heart-failure-with-preserved-ejection-fraction-hfpef/

Study to Evaluate Safety, Tolerability and Drug Levels of ... The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart ...

6. sigma.larvol.com sigma.larvol.com/product.php?e1=826692&tab=newstrac

MYK-224 News While mavacamten has established efficacy, next-generation agents like aficamten may offer improved safety and versatility. ... BMS-986435 (clinicaltrials.gov) - ...