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NCT04471337 · 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 Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04471337: Completed Phase 1 study, sponsored by Bayer.
NCT04471337 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04471337, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 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). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.
Primary Outcome
AUCu: Area under the Curve unbound
Interventions
- DRUG BAY1817080
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2021-05-06 |
| Phase | Phase 1 |
What the finished NCT04471337 record still lists
NCT04471337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which BAY1817080 is the first listed.
NCT04471337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04471337 about?
NCT04471337 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 Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal 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 NCT04471337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-08-12. Estimated completion is 2021-05-06.
What interventions are being tested in trial NCT04471337?
The interventions under investigation include: BAY1817080 (DRUG).
Who is sponsoring clinical trial NCT04471337?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04471337's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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