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Bi 1819479

BI 1819479 is an investigational drug currently being studied in clinical trials for its potential to treat Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition. These trials aim to evaluate the drug’s safety, effectiveness, and how it’s processed in the body. Researchers are conducting studies with both healthy volunteers and IPF patients to gather comprehensive data on this promising new medication.

Table of Contents

What is BI 1819479?

BI 1819479 is a new experimental drug that is currently being studied for its potential to treat Idiopathic Pulmonary Fibrosis (IPF)[1]. This medication is still in the early stages of research, which means it’s not yet available for general use and is only being tested in clinical trials.

What condition does BI 1819479 aim to treat?

The primary focus of BI 1819479 is to treat Idiopathic Pulmonary Fibrosis (IPF)[1]. IPF is a serious lung disease where the tissue in the lungs becomes thick and stiff over time, making it difficult for patients to breathe. The term “idiopathic” means that the cause of this condition is unknown.

Current Clinical Trials

Several clinical trials are currently underway to evaluate BI 1819479:

  • A study testing whether BI 1819479 improves lung function in people with IPF[1]. This trial is testing three different doses of the drug compared to a placebo (a dummy pill with no active ingredient) over a period of 6 months to 1 year.
  • A study to test how healthy women tolerate different doses of BI 1819479[2]. This trial aims to investigate the safety and how the body processes the drug in healthy female participants.
  • A study in healthy men to test how the drug esomeprazole affects the amount of BI 1819479 in the blood[3]. This is important to understand how BI 1819479 might interact with other medications.
  • Studies in healthy men to test how well different doses of BI 1819479 are tolerated and absorbed by the body, with or without food[4][5].

How BI 1819479 Works

While the exact mechanism of how BI 1819479 works is not explicitly stated in the available information, we can infer some details based on the nature of the clinical trials:

  • The drug is being tested for its ability to improve lung function in IPF patients[1]. This suggests that BI 1819479 may have properties that help slow down or potentially reverse the scarring process in the lungs.
  • Researchers are measuring the Forced Vital Capacity (FVC), which is the amount of air a person can forcefully exhale after taking a deep breath. This is a key indicator of lung health in IPF patients[1].

How BI 1819479 is Administered

Based on the clinical trial information, we can deduce that BI 1819479 is taken orally (by mouth) in the form of tablets[1][4]. The dosage and frequency of administration are still being studied to determine the most effective and safe regimen.

Safety and Side Effects

As BI 1819479 is still in the testing phase, its full safety profile and potential side effects are not yet fully known. The ongoing clinical trials are designed to gather this important information:

  • Researchers are closely monitoring for any adverse events (unwanted effects) that may be related to the drug[2][5].
  • The trials are testing different doses to understand how well the drug is tolerated at various levels[1][4].
  • Some studies are specifically looking at how the body processes the drug (pharmacokinetics) to ensure it’s safe and effective[2][4].

Future Prospects

BI 1819479 is still in the early stages of development, but it represents a potential new treatment option for people with Idiopathic Pulmonary Fibrosis. If the current clinical trials show positive results in terms of safety and effectiveness, the drug may progress to larger, more advanced trials. However, it’s important to note that many experimental drugs do not make it through all stages of testing, and it may be several years before BI 1819479 could potentially become available as an approved treatment.

Study Type Participants Main Objectives Key Measurements
IPF Treatment Adults 40+ with IPF Evaluate efficacy and safety of BI 1819479 Lung function (FVC), adverse events
Drug Interaction Healthy men Effect of esomeprazole on BI 1819479 Drug concentration in blood (AUC, Cmax)
Dose Tolerance Healthy men Safety, tolerability, and food effect Adverse events, drug concentration
Female Tolerance Healthy women (non-childbearing) Safety and tolerability of multiple doses Adverse events, drug concentration
Japanese Tolerance Healthy Japanese men Safety and tolerability of single doses Adverse events, drug concentration

FAQ

  • What is BI 1819479? BI 1819479 is an experimental drug being tested as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring in the lungs.
  • What is the main goal of the IPF clinical trial? The main goal is to determine if BI 1819479 can improve lung function in people with IPF. The study is testing three different doses of the drug compared to a placebo.
  • How long do participants take part in the IPF study? Participants are in the study for up to 1 year and 2 months. They take the treatment for 6 months to 1 year and have between 10 and 12 site visits, plus up to 11 phone calls from the study staff.
  • Are there studies with healthy volunteers? Yes, there are several studies involving healthy volunteers. These studies aim to understand how the body processes BI 1819479, its safety, and how well it's tolerated at different doses.
  • What is being measured in these clinical trials? The trials measure various factors, including lung function tests in IPF patients, the concentration of the drug in the blood, how food affects the drug's absorption, and any side effects that may occur.

Ongoing Clinical Trials on Bi 1819479

  • Study on BI 1819479 to Improve Lung Function in Patients with Idiopathic Pulmonary Fibrosis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

Glossary

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease that causes scarring (fibrosis) of the lungs for unknown reasons, leading to difficulty breathing.
  • Placebo: A substance that looks like the study drug but contains no active medication, used to compare the effects of the real drug.
  • Forced Vital Capacity (FVC): A measurement of lung function that shows the amount of air a person can forcefully exhale after taking a deep breath.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • AUC (Area Under the Curve): A measurement used to show the total exposure to a drug over time.
  • Cmax: The maximum concentration of a drug observed in the blood after it's been administered.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it's related to the treatment.

References

  1. https://clinicaltrials.gov/study/NCT06335303
  2. https://clinicaltrials.gov/study/NCT05440799
  3. https://clinicaltrials.gov/study/NCT05467475
  4. https://clinicaltrials.gov/study/NCT04801693
  5. https://clinicaltrials.gov/study/NCT05469646