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Bms-986435

BMS-986435, also known as MYK-224, is an investigational drug currently being studied 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 Preserved Ejection Fraction (HFpEF). The studies involve healthy volunteers and patients, focusing on understanding how the drug behaves in the body and its effects on heart function.

Table of Contents

Overview of BMS-986435

BMS-986435, also known as MYK-224, is a new drug currently being studied in clinical trials[1][2][3]. It is being developed by pharmaceutical companies to potentially treat certain heart conditions and is undergoing various stages of testing to determine its effectiveness and safety.

Conditions Being Studied

The main conditions being investigated for treatment with BMS-986435 include:

  • Heart Failure with Preserved Ejection Fraction (HFpEF): This is a type of heart failure where the heart muscle contracts normally but doesn’t relax properly, leading to reduced blood flow[2].
  • General heart function in healthy individuals: Some studies are looking at how the drug affects the hearts of healthy people, which helps researchers understand its effects and safety profile[1][3].

Current Clinical Trials

There are several ongoing clinical trials for BMS-986435:

  1. Bioavailability Study: This study is looking at how well the body absorbs different tablet formulations of BMS-986435[1].
  2. Heart Failure Study: A Phase 2A study is evaluating the drug’s safety, tolerability, and effects in patients with HFpEF[2].
  3. Study in Chinese Participants: This trial is assessing the drug’s effects specifically in healthy Chinese individuals[3].

Safety and Tolerability

A primary focus of these studies is to assess the safety and tolerability of BMS-986435. Researchers are monitoring:

  • Adverse events (AEs): Any unexpected medical problems that occur during the study[1][2][3].
  • Serious adverse events (SAEs): More severe or life-threatening medical issues[1][2][3].
  • Effects leading to treatment discontinuation: Any problems that cause participants to stop taking the drug[2][3].
  • Changes in vital signs, physical examinations, electrocardiograms (ECGs), and laboratory tests: These help detect any effects the drug might have on various body systems[1][3].

Key Measurements in the Studies

To understand how BMS-986435 works in the body, researchers are measuring:

  • Maximum concentration (Cmax): The highest level of the drug in the blood[1][3].
  • Time to maximum concentration (Tmax): How long it takes to reach the highest blood level[1][3].
  • Area under the curve (AUC): A measure of the total exposure to the drug over time[1][3].
  • Half-life: How long it takes for half of the drug to be eliminated from the body[1].

Effects on Heart Function

In the study involving Chinese participants, researchers are closely examining how BMS-986435 affects various aspects of heart function[3]. They are looking at:

  • Systolic function: How well the heart contracts to pump blood. This includes measures like:
    • Left ventricular ejection fraction (LVEF): The percentage of blood pumped out with each heartbeat.
    • Left ventricular fractional shortening (LVFS): How much the heart’s main pumping chamber shortens during contraction.
    • Left ventricular global longitudinal strain (LV GLS): A measure of the heart muscle’s ability to contract.
  • Diastolic function: How well the heart relaxes and fills with blood. This includes measures like:
    • Early diastolic mitral annular velocity (e’): How fast the heart’s mitral valve ring moves during early filling.
    • E/e’ ratio: A measure of the pressure inside the heart during filling.
  • Heart structure: Physical characteristics of the heart, such as:
    • Left ventricular mass index: A measure of heart muscle thickness.
    • Left atrial volume index: A measure of the size of the heart’s upper left chamber.
    • Wall thickness: The thickness of the heart’s walls.

These detailed measurements help researchers understand how BMS-986435 might affect heart function and structure, which is crucial for determining its potential effectiveness in treating heart conditions like HFpEF.

Aspect Details
Drug Name BMS-986435 (also known as MYK-224)
Study Types Phase 1 and Phase 2A clinical trials
Participants Healthy volunteers and patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
Main Objectives Assess safety, tolerability, pharmacokinetics, and pharmacodynamics
Key Measurements Drug concentration in blood, heart function parameters, adverse events
Study Designs Randomized, placebo-controlled, single and multiple dose studies
Duration Varies from 5 months to 24 weeks, depending on the study

FAQ

  • What is BMS-986435? BMS-986435, also known as MYK-224, is an investigational drug being studied for its potential benefits in heart health, particularly for patients with Heart Failure with Preserved Ejection Fraction (HFpEF).
  • What are the main goals of the clinical trials involving BMS-986435? The main goals are to assess the safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the drug's effects on the body) of BMS-986435 in both healthy participants and those with heart conditions.
  • Who can participate in these clinical trials? The trials involve both healthy volunteers and patients with heart failure, specifically those with Heart Failure with Preserved Ejection Fraction (HFpEF). Some trials focus on specific populations, such as healthy Chinese participants.
  • What are some of the outcomes being measured in these trials? The trials measure various outcomes, including the drug's concentration in the blood, its effects on heart function (such as ejection fraction and cardiac structure), and the incidence of adverse events or side effects.
  • How long do these clinical trials typically last? The duration of the trials varies. Some studies last up to approximately 5 months, while others may continue for up to 24 weeks. The exact duration depends on the specific trial design and objectives.

Ongoing Clinical Trials on Bms-986435

  • Study on the Effects of MYK-224 for Patients with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Spain

  • Study on the Safety and Tolerability of BMS-986435 in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

    Not recruiting

    1 1
    Investigated drugs:
    Italy Poland Spain

Glossary

  • Bioavailability: The extent and rate at which a drug enters the body's circulation and becomes available at the site of action.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of a drug's effects on the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Heart Failure with Preserved Ejection Fraction (HFpEF): A type of heart failure where the heart's ability to relax and fill with blood is impaired, but its ability to pump blood out (ejection fraction) is relatively normal.
  • Ejection Fraction: The percentage of blood that the heart pumps out with each contraction.
  • Echocardiogram: An ultrasound test that uses sound waves to create images of the heart, allowing doctors to evaluate its structure and function.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Placebo: An inactive substance that looks like the drug being tested, used in clinical trials to help determine the true effects of the investigational drug.

References