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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

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Moxifloxacin

+ Placebo

+ Elinzanetant (BAY3427080)

Medicamento
Quiénes están siendo reclutados

Enfermedades del Sistema Endocrino+7

+ Neoplasias de Glándulas Endocrinas

+ Enfermedades y Anomalías Congénitas, Hereditarias y Neonatales

De 18 a 55 años
+15 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Ciencia Básica

Fase 1
Intervencional
Inicio del estudio: agosto de 2022
Ver detalles del protocolo

Resumen

Patrocinador PrincipalBayer
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 19 de agosto de 2022

Fecha en la que se inscribió al primer participante.

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.

Título OficialA 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
Patrocinador PrincipalBayer
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 51 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Ciencia Básica

Los estudios de ciencia básica ayudan a los investigadores a comprender cómo funciona el cuerpo o cómo se desarrolla una enfermedad. No prueban tratamientos, pero sientan las bases para terapias futuras.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 55 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades del Sistema EndocrinoNeoplasias de Glándulas EndocrinasEnfermedades y Anomalías Congénitas, Hereditarias y NeonatalesNeoplasiasNeoplasias Múltiples PrimariasNeoplasias por SitioNeoplasia Endocrina MúltipleSíndromes Neoplásicos HereditariosSignos y SíntomasCondiciones Patológicas, Signos y Síntomas

Criterios

5 criterios de inclusión requeridos para participar
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 criterios de exclusión impiden participar
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.

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

6 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
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.

Grupo II

Experimental
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.

Grupo III

Experimental
Single oral dose of elinzanetant or placebo.

Grupo IV

Experimental
Single oral dose of elinzanetant or placebo

Grupo 5

Experimental
Single oral dose of elinzanetant or placebo

Grupo 6

Experimental
Single oral dose of elinzanetant or placebo

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

NUVISAN GmbH Neu-Ulm

Neu-Ulm, GermanyAbrir NUVISAN GmbH Neu-Ulm en Google Maps
Completado1 Centros de Estudio