Last reviewed · How we verify
NCT05028608
A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.
Phase 1 trial testing Elinzanetant (BAY3427080) in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men in 16 participants. Completed in 20 January 2022.
31 October 2021
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 16 |
| Start date | 6 September 2021 |
| Primary completion | 31 October 2021 |
| Estimated completion | 20 January 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Elinzanetant (BAY3427080) — full drug profile →
- Midazolam (midazolam) — full drug profile →
- Carbamazepine (carbamazepine) — full drug profile →
Conditions studied
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men — all drugs for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 60, any sex, with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body. In this study researchers want to learn more about a new substance called elinzanetant. Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal changes, such as hot flashes. Carbamazepine is a drug that is already available for doctors to prescribe, for example against seizures. Midazolam is a treatment that is already available for doctors to prescribe as a sedative (calming treatment) or to help people sleep. In this study, the researchers will learn how much elinzanetant gets into the participants' blood when taken with or without carbamazepine. They will also get to know if taking elinzanetant will affect the amount of midazolam in the blood. The participants will all take elinzanetant as capsules, carbamazepine as tablets and midazolam as a liquid by mouth. On some days, they will take only 1 treatment of midazolam or carbamazepine or only elinzanetant. On other days, they will take two study treatments. On 3 different days during the study, the participants will take elinzanetant with midazolam, elinzanetant with carbamazepine and midazolam with carbamazepine. Each participant will be in the study for up to 10 weeks. But, the entire study will last about 4 months. During the study, all of the participants will stay at the study site for 2 periods, period 1 with 9 overnight stays and period 2 with 22 overnight stays at the study site. In addition, there will be two ambulatory visits, one before joining the study and one at the end of the study. Blood and urine samples will be collected. The doctors will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how they are feeling and about any medications they are taking.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05028608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Elinzanetant (BAY3427080)
Trials testing the same drug.
- NCT06219902 — A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women · Phase 1 · completed
- NCT05587296 — A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot · Phase 3 · active not recruiting
- NCT05481528 — A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Gi · Phase 1 · completed
- NCT05471817 — A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through a · Phase 1 · completed
- NCT05381142 — A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body · Phase 1 · completed
Other recruiting trials for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Currently open trials in the same condition.
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05028608 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 25 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05028608.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing