MYK-224 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By First line of 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: Unknown

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, MYK-224, to evaluate its safety and how the body processes it. The focus is on administering varying doses to healthy Japanese adults to observe the drug's behavior in the body. Participants may receive either the drug or a placebo (a non-active substance) for comparison. The trial seeks Japanese adults who are generally healthy, with normal heart function and no history of heart disease. 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 is for healthy participants without any acute or chronic medical illnesses, so it seems likely that you should not be on any current medications. However, the protocol does not specify this explicitly.

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

Research has shown that MYK-224 underwent safety testing in earlier studies. These studies assessed how well participants tolerated MYK-224. So far, MYK-224 has been well-tolerated, with most participants experiencing no serious side effects. Some reported mild side effects, such as headaches or nausea, but these were not severe.

Since MYK-224 remains in the early testing stages, researchers continue to study its full safety profile, monitoring for any new or rare side effects. Overall, the treatment has been deemed safe enough to continue human testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MYK-224 because it offers a new mechanism of action that targets the underlying causes of the condition it's designed to treat. Unlike standard treatments, which often focus on symptom management, MYK-224 directly addresses the root of the problem, potentially leading to more effective and long-lasting results. Additionally, MYK-224 is being assessed for its safety and tolerability in healthy adults, which could pave the way for broader applications and improved patient outcomes in the future.

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

Research has shown that MYK-224, which participants in this trial may receive, could be a promising treatment for certain heart conditions. It resembles another drug, mavacamten, which addresses heart muscle issues by reducing extra contractions. MYK-224 is designed to act faster because it remains in the body for a shorter duration. Early findings suggest it may effectively treat conditions like hypertrophic cardiomyopathy, where the heart muscle thickens excessively. Although more research is necessary, these early signs are encouraging for its potential in improving heart health. ^{2 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?

Inclusion Criteria

Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments

Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

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 MYK-224 to evaluate safety, tolerability, and pharmacokinetics

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MYK-224
• Placebo

How Is the Trial Designed?

Group I: Arm 4 Experimental Treatment 2 Interventions

Group II: Arm 3 Experimental Treatment 2 Interventions

Group III: Arm 2 Experimental Treatment 2 Interventions

Group IV: Arm 1 Experimental Treatment 2 Interventions

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

A machine-learning model was developed using data from 4638 patients across 16 FDA-approved small molecule kinase inhibitors (SMKIs) to analyze the relationship between kinase targets and adverse events (AEs), providing a new tool for predicting safety risks in cancer treatments.

The model not only helps identify potential kinase-inhibitor adverse event pairs but also serves as a precision medicine tool to enhance patient safety by forecasting clinical safety signals and aiding in the development of safer SMKI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decoding kinase-adverse event associations for small molecule kinase inhibitors. Gong, X., Hu, M., Liu, J., et al.[2022]

MK-8389 was found to be generally safe and well tolerated in healthy young women over a 14-day period, although it caused transient changes in thyroid function tests that limited dose escalation above 40 mg.

While MK-8389 showed acceptable systemic exposure, it did not have a clinically meaningful effect on follicular development, although higher doses did increase inhibin B levels, indicating some early follicular activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral follicle-stimulating hormone agonist tested in healthy young women of reproductive age failed to demonstrate effect on follicular development but affected thyroid function. Gerrits, MG., Kramer, H., el Galta, R., et al.[2016]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383798/

Cardiac Myosin Inhibitors in the Treatment of Hypertrophic ... MYK-224, a structural analog of mavacamten, is currently in Phase II trials. It is designed with a shorter half-life to offer greater dosing ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-myk-224-in-participants-with-symptomat

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

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

BMS-986435: A Promising New Drug in Clinical Trials Study on the Effects of MYK-224 for Patients with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction. Not Recruiting.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05556343?term=AREA%5BBasicSearch%5D(Disopyramide)&rank=4

A Study to Evaluate the Efficacy, Safety, and Tolerability of ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

6. abmole.com abmole.com/literature/myk-224-msds.html?srsltid=AfmBOopCX6ZZ8nl8RizCpMqrH91WsaqaBm3GrFXRun7SK0FoW_sHDaAE

Material Safety Data Sheet of MYK-224 Material Safety Data Sheet of MYK-224 contains identification of substance and details of the supplier of the safety data sheet.

7. bmsstudyconnect.com bmsstudyconnect.com/ca/en/clinical-trials/NCT05556343.html

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

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05405543

A Study to Evaluate the Safety, Tolerability, and Drug ... A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants.

9. 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).