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NCT07023354 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
A Phase 1 study of Healthy and Hepatic Impairment, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT07023354 is a Phase 1 study of Healthy and Hepatic Impairment that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT07023354, a Phase 1 study of Healthy and Hepatic Impairment, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. 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 being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood. Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons. Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG BI 1291583
Study Locations (3)
Texas
- Tranquil Clinical Research - Houston
- American Research Corporation at the Texas Liver Institute - San Antonio
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-06-25 |
| Est. Completion | 2026-07-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07023354
The ClinicalTrials.gov registry entry for NCT07023354 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which BI 1291583 is the first listed.
NCT07023354 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT07023354 about?
NCT07023354 is a clinical study titled "A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems". This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with an...
What is the current status of trial NCT07023354?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-06-25. Estimated completion is 2026-07-04.
What conditions does trial NCT07023354 study?
This clinical trial studies the following conditions: Healthy, Hepatic Impairment.
What interventions are being tested in trial NCT07023354?
The interventions under investigation include: BI 1291583 (DRUG).
Who is sponsoring clinical trial NCT07023354?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07023354 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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