Terminé

A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants

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Ce qui est testé

Moxifloxacin

+ Placebo

+ Elinzanetant (BAY3427080)

Médicament
Qui peut participer

Maladies du système endocrinien+10

+ Néoplasmes des glandes endocrines

+ Maladies et anomalies congénitales, héréditaires et néonatales

De 18 à 55 ans
+15 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Recherche fondamentale

Phase 1
Interventionnel
Date de début : août 2022
Voir le détail du protocole

Résumé

Sponsor principalBayer
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 19 août 2022

Date à laquelle le premier participant a commencé l'étude.

Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men. 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 it in people with vasomotor symptoms. In previous studies, elinzanetant doses tested and resulting blood levels were close to the levels intended for treatment. However, in future use, it cannot always be ruled out that higher elinzanetant concentrations may occur in the blood if patients are taking certain other drugs at the same time, or take more than the recommended dose of the drug. The main purpose of this study is to learn how safe elinzanetant is when higher doses than normally used are given compared to placebo in healthy participants. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, researchers will compare the number of participants who have medical problems after taking elinzanetant to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. The study consists of two parts. In part 1, the participants will either take a single dose of elinzanetant or placebo by mouth dependent on the treatment group. Four different increasing doses of elinzanetant will be tested. Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment in part 1, the participants will receive a single dose of moxifloxacin and a single dose of placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart rhythm can be detected in the study. Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 \& 2). Participants of part 1 will stay in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The in-house phase starts two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned. During the study, the study team will: * Do physical examinations * Check vital signs * Take blood and urine samples * Examine the participants' heart health using electrocardiogram (ECG) * Ask the participants questions about their mood and about sleepiness.

Titre officielA Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants
NCT05481528
Sponsor principalBayer
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

51 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche fondamentale

Cette étude cherche à mieux comprendre les mécanismes biologiques à l'origine d'une maladie ou d'un problème de santé, sans viser directement un traitement.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 55 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies du système endocrinienNéoplasmes des glandes endocrinesMaladies et anomalies congénitales, héréditaires et néonatalesNéoplasie Endocrinienne MultipleNéoplasmes par siteNéoplasmesNéoplasmes Multiples PrimairesSyndromes néoplasiques héréditairesSignes et symptômesConditions pathologiques, signes et symptômesNéoplasie Endocrinienne Multiple de Type 1Bouffées de chaleurMaladies Génétiques Congénitales

Critères

5 critères d'inclusion nécessaires pour participer
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature and electrocardiogram (ECG).

Body weight of at least 50 kg.

Body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive).

Male subjects of reproductive potential must agree to use a condom (with or without spermicide) when sexually active with a female partner and refrain from donating sperm. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Female partners of childbearing potential of male subjects do not need to follow special precautions.

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10 critères d'exclusion empêchent la participation
Any clinically relevant abnormal findings in medical history and physical examination. Including: History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.

Known or suspected hypersensitivity or allergy to the study interventions or other fluoroquinolone products.

Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.

Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency.

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

6 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Participants of Dose Groups 1 and 4 will receive a single dose of moxifloxacin in Period 1 and a single dose of placebo in Period 2.

Groupe II

Expérimental
Participants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2.

Groupe III

Expérimental
Single oral dose of elinzanetant or placebo.

Groupe IV

Expérimental
Single oral dose of elinzanetant or placebo

Groupe 5

Expérimental
Single oral dose of elinzanetant or placebo

Groupe 6

Expérimental
Single oral dose of elinzanetant or placebo

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

NUVISAN GmbH Neu-Ulm

Neu-Ulm, GermanyOuvrir NUVISAN GmbH Neu-Ulm dans Google Maps
Terminé1 Centres d'Étude