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Bi 765845

BI 765845 is a new medication currently being studied in clinical trials to help people who have recently experienced a heart attack. These trials aim to evaluate the drug’s effectiveness, safety, and how well it is tolerated by patients. The studies involve both heart attack patients and healthy volunteers to gather comprehensive data on the drug’s potential benefits and side effects.

Table of Contents

What is BI 765845?

BI 765845 is a new investigational drug being developed to help people who have recently experienced a heart attack, also known as a myocardial infarction[1]. A heart attack occurs when blood flow to a part of the heart is blocked, usually by a blood clot, causing damage to the heart muscle. This medication is currently undergoing clinical trials to assess its effectiveness and safety in treating patients who have suffered from this serious cardiovascular event.

How Does BI 765845 Work?

While the exact mechanism of action is not explicitly stated in the provided information, BI 765845 is being studied for its potential to reduce infarct size[1]. Infarct size refers to the amount of heart muscle damaged during a heart attack. By potentially reducing this damage, BI 765845 may help improve outcomes for heart attack patients.

Clinical Trials

BI 765845 is currently being evaluated in several clinical trials:

  1. IRI-EXPLORE Study: This is a large-scale trial involving adults aged 18 and over who have recently had a heart attack. The study aims to test different doses of BI 765845 and assess how well they work compared to a placebo[1].
  2. Japanese Safety Study: This trial focuses on testing the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of BI 765845 in healthy Japanese men[2].
  3. General Safety Study: This study investigates the safety, tolerability, and pharmacokinetics of BI 765845 in healthy male subjects and female subjects who cannot bear children[3].

Potential Benefits

The main potential benefit of BI 765845 is its ability to reduce the size of the damaged area in the heart after a heart attack. Researchers are measuring this by looking at the percentage of left ventricular mass that is infarcted (damaged) using a special imaging technique called late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR)[1]. If successful, this could lead to better recovery and outcomes for heart attack patients.

Safety and Tolerability

A significant focus of the ongoing clinical trials is to assess the safety and tolerability of BI 765845. Researchers are carefully monitoring for any treatment-emergent adverse events (side effects that occur during treatment) and how they relate to the drug[2][3]. This information will help determine the optimal dosage and identify any potential risks associated with the medication.

Administration

Based on the information provided, BI 765845 is administered intravenously (through a vein)[2][3]. The trials are testing various doses and treatment regimens to determine the most effective and safe approach for patients.

Future Prospects

As BI 765845 is still in the clinical trial phase, it is not yet available for general use. The results of these studies will determine whether the drug is effective and safe enough to be approved for treating heart attack patients. If successful, BI 765845 could become an important addition to the standard of care for individuals who have experienced a heart attack, potentially improving their recovery and long-term outcomes[1].

Aspect Details
Drug Name BI 765845
Main Condition Studied Myocardial Infarction (Heart Attack)
Administration Method Intravenous (through a vein)
Main Trial Duration 3 months
Primary Outcome Measure Infarct size (percentage of damaged left ventricular mass)
Imaging Technique Cardiac Magnetic Resonance (CMR) with Late Gadolinium Enhancement (LGE)
Additional Studies Safety and pharmacokinetics in healthy volunteers

FAQ

  • What is BI 765845? BI 765845 is a new medication being tested in clinical trials to potentially help people who have recently had a heart attack. It is administered intravenously (through a vein).
  • Who can participate in the BI 765845 clinical trials? The main trial is open to adults aged 18 and over who have just had a heart attack. There are also separate trials for healthy male Japanese subjects and healthy male and female subjects of non-childbearing potential.
  • How long do the clinical trials last? The main trial for heart attack patients lasts for 3 months. During this time, participants visit the study site 7 times and receive 3 phone calls from the site staff.
  • What are the main goals of these clinical trials? The main objectives are to investigate the safety, tolerability, and effectiveness of BI 765845. The trials also aim to determine how well different doses work and how the body processes the drug (pharmacokinetics).
  • How is the effectiveness of BI 765845 measured in heart attack patients? The effectiveness is primarily measured by examining the infarct size (area of heart damage) using cardiac magnetic resonance imaging. This is done by looking at the percentage of left ventricular mass that is infarcted.

Ongoing Clinical Trials on Bi 765845

  • Study to Test BI 765845 for Patients with Heart Attack

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Italy Poland Slovakia +1

Glossary

  • Myocardial Infarction: The medical term for a heart attack, which occurs when blood flow to part of the heart is blocked, causing damage to the heart muscle.
  • Placebo: A substance that looks like the real medication but contains no active drug. It's used in clinical trials to compare the effects of the actual drug against no treatment.
  • Infarct size: The amount of heart muscle damaged during a heart attack. It's usually measured as a percentage of the left ventricle (main pumping chamber of the heart) that is affected.
  • Late Gadolinium Enhancement (LGE): A technique used in cardiac magnetic resonance imaging to visualize and measure areas of heart muscle damage after a heart attack.
  • Cardiac Magnetic Resonance (CMR): An imaging technique that uses powerful magnets and radio waves to create detailed pictures of the heart, allowing doctors to assess heart structure and function.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Intravenous administration: A method of giving medication directly into a vein using a needle or tube.
  • Treatment-emergent adverse event: Any unfavorable or unintended sign, symptom, or disease that appears or worsens after starting a medical treatment.

References

  1. https://clinicaltrials.gov/study/NCT06139328
  2. https://clinicaltrials.gov/study/NCT06139341
  3. https://clinicaltrials.gov/study/NCT06139315