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NCT05351892 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05351892 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 18 participants.
The verdict
NCT05351892, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use elinzanetant in people with vasomotor symptoms. In previous studies, capsules containing smaller amounts of elinzanetant have been used. To reach the daily dose intended for treatment, 3 of these capsules had to be taken once a day. To reduce the pill burden and make it easier for patients to stick to the treatment, capsules with a higher amount of elinzanetant have been developed. The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when the same dose is taken as new capsule formulation compared to the old capsule formulation. To answer this question, the researchers will compare: * The (average) total level of elinzanetant in the blood (also called AUC) * The (average) highest level of elinzanetant in the blood (also called Cmax) between both capsule formulations after taking one dose of each. In addition, the researchers want to compare how much of the new and old elinzanetant formulations get into the blood after intake for 9 subsequent days. All participants will take both formulations by mouth during the study. Each participant will be in the study for up to 12 weeks, including 10 treatment days for each formulation. Participants will stay in-house for 14 days per capsule formulation. In addition, one screening visit to the study site is planned. During the study, the study doctor and their team will: * Do physical exa
Interventions
- DRUG Elinzanetant (BAY3427080)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-05-04 |
| Est. Completion | 2022-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05351892
The ClinicalTrials.gov registry entry for NCT05351892 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 1 intervention - of which Elinzanetant (BAY3427080) is the first listed.
NCT05351892 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05351892 about?
NCT05351892 is a clinical study titled "A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants". Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurok...
What is the current status of trial NCT05351892?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-05-04. Estimated completion is 2022-06-20.
What interventions are being tested in trial NCT05351892?
The interventions under investigation include: Elinzanetant (BAY3427080) (DRUG).
Who is sponsoring clinical trial NCT05351892?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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