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NCT04903821
A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants
Phase 1 trial testing BAY3427080 in Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men in 33 participants. Completed in 15 March 2022.
15 March 2022
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 33 |
| Start date | 1 June 2021 |
| Primary completion | 15 March 2022 |
| Estimated completion | 15 March 2022 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- BAY3427080 — 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
18 and older, 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, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. 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. The study drug, elinzanetant, was designed to treat vasomotor symptoms. The liver plays an important role in removing elinzanetant from the body. Therefore, this study is done to find out how reduced liver function influences the removal of elinzanetant. The study will include male and female participants who are 18 to 75 years old. One part of the participants will have mildly or moderately impaired hepatic function. For each group with impaired hepatic function, a group with normal hepatic function will be included. Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about their well-being and taken medications. The researchers will compare the blood levels of elinzanetant in the participants with impaired hepatic function to those of the matched participants with normal hepatic function. This way, they can see how blood levels of elinzanetant are influenced by liver function. This information is important for giving recommendations on dosing in patients with impaired hepatic function.
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 NCT04903821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BAY3427080
Trials testing the same drug.
- NCT02865538 — Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms · Phase 1, PHASE2 · 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 NCT04903821 (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: 24 March 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/NCT04903821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing