BMS-986435 for Healthy Adults

Recruiting at 1 trial location

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cardiac abnormality, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new tablet forms of a treatment called BMS-986435 to evaluate their effectiveness compared to the original version. Researchers aim to determine if food intake affects the treatment's efficacy. The trial includes several groups, each testing a different tablet version. Individuals who are generally healthy, have stable heart function, and meet specific weight and body mass criteria may qualify for this study. 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 treatment.

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.

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

Research has shown that BMS-986435 has undergone safety testing in several studies. Participants in these studies received either a single dose or multiple doses of the drug. Most did not experience serious side effects, indicating that the treatment was generally well-tolerated. Some reported mild side effects, but these were uncommon.

Additionally, this treatment has been studied in individuals with heart conditions, focusing on safety and the body's reaction to the drug. These studies also found BMS-986435 to be well-tolerated, with few negative effects. This suggests that the treatment is likely safe for most clinical trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

BMS-986435 is unique because it offers a fresh approach to treatment with its novel mechanism of action. Unlike current options that rely on conventional pathways, BMS-986435 targets an innovative pathway that could lead to more effective results. Researchers are excited about its potential to work faster and more efficiently, possibly reducing the time needed to see improvements. This new angle could offer significant benefits over standard treatments, making it a promising option for future care.

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

Research has shown that BMS-986435 may help treat heart conditions, particularly Heart Failure with preserved Ejection Fraction (HFpEF). Early studies suggest this drug aids the heart muscle in relaxing and functioning better, potentially reducing symptoms for those with HFpEF. Patients who previously used BMS-986435 demonstrated improvements in heart function. This trial will test various treatment arms to assess BMS-986435's safety, effectiveness, and mechanism in the body. While specific results in humans are still being gathered, these early findings are promising. ^{5 6 7 8 9}

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. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no significant medical conditions.

Inclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

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

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

Participants receive multiple test tablet formulations of BMS-986435 to assess relative bioavailability and the effect of food on the selected formulation

6-8 weeks

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 a drug called BMS-986435 in comparison to its standard form. It will also look at how food affects the drug's absorption.

How Is the Trial Designed?

Group I: Treatment G Experimental Treatment 1 Intervention

Group II: Treatment F Experimental Treatment 1 Intervention

Group III: Treatment E Experimental Treatment 1 Intervention

Group IV: Treatment D Experimental Treatment 1 Intervention

Group V: Treatment C Experimental Treatment 1 Intervention

Group VI: Treatment B Experimental Treatment 1 Intervention

Group VII: Treatment A Experimental Treatment 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/NCT07226817

A Study to Assess the Relative Bioavailability of BMS ... A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants. ClinicalTrials ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07226817?rank=1

A Study to Assess the Relative Bioavailability of BMS ... A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants. ClinicalTrials ...

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. trial.medpath.com trial.medpath.com/clinical-trial/874fa4f1e68b0d77/nct06122779-bms-986435-myk-224-heart-failure-hfpef

Study to Evaluate Safety, Tolerability and Drug Levels of BMS ... 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 ...

5. withpower.com withpower.com/trial/phase-2-heart-failure-10-2023-3f773

BMS-986435 for Heart Failure (AURORA-HFpEF Trial) Early studies suggest that this drug aids the heart muscle in relaxing and functioning better, potentially improving symptoms for people with HFpEF, a type of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05405543

A Study to Evaluate the Safety, Tolerability, and Drug ... The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants. Official ...

7. 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 ...

8. 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).

9. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-safety-tolerability-and-drug-levels-of-bms-986435-myk-224-in-participants-with-he

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