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NCT04454424 · ClinicalTrials.gov registry record · Phase 1
Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT04454424 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 37 participants.
The verdict
NCT04454424, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). In this study researchers want to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as tablet in participants with mild, moderate or severe hepatic impairment and participants with normal liver function matched for age-, gender-, weight and race. The study will enroll 36 male and female participants in the age between 18 and 79 years. Participants with mild or moderate hepatic impairment and the matching participants will take multiple oral doses of study drug depending on the study plan. Participants with severe hepatic impairment and the matching participants will take a single oral dose of study drug during the study. Data from this study will provide researcher important information for further development of the study drug in particular on dose recommendation for patients with hepatic impairment.
Interventions
- DRUG Midazolam
- DRUG BAY1817080
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04454424
The ClinicalTrials.gov registry entry for NCT04454424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT04454424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04454424 about?
NCT04454424 is a clinical study titled "Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function". BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a con...
What is the current status of trial NCT04454424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-07-23. Estimated completion is 2021-12-15.
What interventions are being tested in trial NCT04454424?
The interventions under investigation include: Midazolam (DRUG), BAY1817080 (DRUG).
Who is sponsoring clinical trial NCT04454424?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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