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NCT05071729 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05071729: Completed Phase 1 study, sponsored by Bayer.
NCT05071729 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05071729, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS). The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no longer have their period. Hormones are substances in the blood that help body organs to work in specific ways. Women who no longer have their period may have a protein called neurokinin sending more signals than usual to other parts of the body. Researchers think that this may play a role in causing VMS. In this study, the researchers want to learn more about a new substance called elinzanetant. Researchers think elinzanetant may help people with VMS. It works by blocking neurokinin from sending signals to other parts of the body. There are treatments available for VMS, but these do not work for all people and may cause medical problems for some people. The main purpose of this study is to help the researchers learn more about how elinzanetant moves into, through and out of the body in participants with kidneys that do not work as well as they should compared to healthy participants whose kidneys work normally. To do this, the doctors will take blood samples from the participants at different times during the study and measure the levels of elinzanetant in the blood. This will help the researchers learn more about whether elinzanetant could be given to treat VMS in people who also have kidneys that do not work as well as they should. This study will include adult participants who have kidneys that do not work as well as they should and participants whose kidneys work normally. The participants who have kidneys that do not work as well as they should will be split into 2 groups based on how severe their kidney problems are. All of the participants will take elinzanetant once as a tablet by mouth. The participants will be in the study for about 1 month and will stay at t
Primary Outcome
Measured matrix after a single dose administration.
Interventions
- DRUG Elinzanetant (BAY3427080)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2022-10-19 |
| Phase | Phase 1 |
What the finished NCT05071729 record still lists
NCT05071729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Elinzanetant (BAY3427080) is the first listed.
NCT05071729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05071729 about?
NCT05071729 is a clinical study titled "A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally". Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS). The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no l...
What is the current status of trial NCT05071729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-10-14. Estimated completion is 2022-10-19.
What interventions are being tested in trial NCT05071729?
The interventions under investigation include: Elinzanetant (BAY3427080) (DRUG).
Who is sponsoring clinical trial NCT05071729?
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 NCT05071729's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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