BI 1291583 for Liver Disease

Recruiting at 1 trial location

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Severe renal, CNS diseases, others

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

Compensation: Varies

Number of Visits: 12

Duration: 3 days

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 1291583, to observe its behavior in the blood of individuals with and without liver problems. Although researchers are developing BI 1291583 to treat bronchiectasis (a lung disease), many affected individuals also experience liver issues, making it essential to understand how liver health influences the medicine. Participants will take a single dose of BI 1291583 and will be grouped based on liver health, ranging from no issues to severe problems. This trial may suit individuals with chronic liver issues and those without liver problems. Participants will visit the study site multiple times over approximately three months for health checks and blood tests. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that your current medications be stable, meaning no dose changes, for at least 7 days or 5 half-lives before starting the trial and should remain stable throughout the study. If your treatment is not stable, it may still be considered if your condition is under control, but this needs approval from the investigator and the sponsor's medical monitor.

Is there any evidence suggesting that BI 1291583 is likely to be safe for humans?

Research has shown that BI 1291583 has undergone safety testing in other studies. The results indicate that the treatment's benefits outweigh the risks at the tested doses. No major safety concerns or issues with the drug's metabolism in the body were identified, suggesting that BI 1291583 is generally well-tolerated. However, as this trial remains in the early stages, researchers are closely monitoring BI 1291583 to ensure safety, particularly for individuals with liver problems. Participants in this trial will receive regular check-ups for any side effects, and doctors will carefully monitor their health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver disease?

BI 1291583 is unique because it offers a new approach to treating liver disease by potentially addressing various levels of liver impairment. While most existing treatments focus on managing symptoms or slowing disease progression, BI 1291583 may work differently, possibly targeting the underlying causes of liver dysfunction. This novel mechanism of action gives researchers hope that it could offer more effective relief and improved outcomes for patients with mild to severe liver impairment. Additionally, the excitement stems from its potential to fill gaps where current therapies may fall short, offering a more tailored and comprehensive treatment option.

What evidence suggests that BI 1291583 might be an effective treatment for bronchiectasis?

Research has shown that BI 1291583 is being developed to help people with bronchiectasis, a long-term lung condition. Early results suggest that BI 1291583 is generally safe at the doses tested. In some studies, lower doses of BI 1291583 proved more effective and caused fewer side effects than higher doses. The treatment aims to improve lung health by reducing flare-ups in people with bronchiectasis. This trial will evaluate BI 1291583 in participants with varying degrees of liver impairment, as well as in healthy participants with normal liver function, to assess its safety and effects on liver disease. Although specific information about its effects on liver disease is not yet available, the drug appears promising for lung issues. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-80 with a BMI of 18.5 to 42 kg/m², both healthy and those with liver problems, can join this study. It's designed to understand how the drug BI 1291583 is absorbed in people with varying liver function.

Inclusion Criteria

Body Mass Index (BMI) of 18.5 to 42 kg/m²

I am between 18 and 80 years old.

My liver function is not normal, but meets specific requirements.

Exclusion Criteria

I have a long-lasting or recent infection.

Any medical condition or finding in the medical examination that poses a safety risk for the trial participant or may interfere with the study objectives

I do not have severe health issues like heart, kidney, or lung problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of BI 1291583 and are monitored for pharmacokinetics and safety

3 days

3 days at the study site

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular health checks and blood sample collection

up to 3 months

up to 9 visits

What Are the Treatments Tested in This Trial?

Interventions

• BI 1291583

Trial Overview The trial tests how much of the lung disease medication BI 1291583 enters the blood in individuals with different levels of liver health. Participants are grouped by their liver function and receive a single dose for comparison.

How Is the Trial Designed?

Group I: Group 4: Healthy trial participants with normal liver function Experimental Treatment 1 Intervention

Matched to 8 demographic clusters generated from the 24 trial participants of Groups 1 through 3.

Group II: Group 3: Participants with severe liver impairment Experimental Treatment 1 Intervention

Child-Pugh classification C; score of 10-15 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.

Group III: Group 2: Participants with moderate liver impairment Experimental Treatment 1 Intervention

Child-Pugh classification B; score of 7 - 9 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.

Group IV: Group 1: Participants with mild liver impairment Experimental Treatment 1 Intervention

Child-Pugh classification A; score of 5 - 6 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05238675

NCT05238675 | A Study to Test Whether Different Doses of ... A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671317/

A randomized phase I study of the safety and ... The results show that BI 1291583 has an appropriate benefit–risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied.

3. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-003304-41/DK

Clinical Trials Register The secondary objective is to assess superiority of BI 1291583 5 mg versus placebo on the primary endpoint, the time to first pulmonary ...

4. synapse.patsnap.com synapse.patsnap.com/drug/17fb7fdf3a0440558ebf7f39a2c55c7e

Verducatib - Drug Targets, Indications, Patents BI 1291583 2.5 mg showed numerically better efficacy compared with 5 mg across several end-points; 1 mg was similar to placebo. The safety profile of BI 1291583 ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20587316

A Study To Find Out Whether BI 1291583 Helps People ... The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07023354

NCT07023354 | A Study to Test How BI 1291583 is Taken ... The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is ...

7. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/medinfo/research-development/clinical-trials/details/nct05238675

Study Details | BIPI Medical & Clinical Resources A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least ...