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NCT03842761 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT03842761 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 64 participants.
The verdict
NCT03842761, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[Child-Turcotte-Pugh (CTP) classification A and B\] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers
Interventions
- DRUG Placebo
- DRUG BI 685509
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-03-06 |
| Est. Completion | 2021-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03842761
The ClinicalTrials.gov registry entry for NCT03842761 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03842761 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03842761 about?
NCT03842761 is a clinical study titled "A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems". The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[Child-Turcotte-Pugh (CTP) classification A and B\] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokin...
What is the current status of trial NCT03842761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2019-03-06. Estimated completion is 2021-05-20.
What interventions are being tested in trial NCT03842761?
The interventions under investigation include: Placebo (DRUG), BI 685509 (DRUG).
Who is sponsoring clinical trial NCT03842761?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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