Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: (+)1-888-84 22937
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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Quebec
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Mount Royal, Quebec, Canadá, H3P 3P1
- Reclutamiento
- Altasciences
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- Signed informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
- Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- Febrile illness within 2 weeks prior to first administration of study intervention.
- History of clinically relevant seizures or endometrial tumors.
- Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
- Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.
- Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- Smoking more than 10 cigarettes per day within 3 months prior to screening.
- Special diets incompatible with study requirements or inability to comply with study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
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Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
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Experimental: Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
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Elinzanetant treatment A is administered orally once daily.
Elinzanetant treatment B is administered orally once daily.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Periodo de tiempo: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
Periodo de tiempo: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
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elinzanetant administered in the evening 3 hours after a light dinner.
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On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
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Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
Periodo de tiempo: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
elinzanetant administered in the evening 3 hours after a light dinner.
|
On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number and Severity of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
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From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days)
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Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))
Periodo de tiempo: On Day 2 of each 12-day treatment period
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elinzanetant administered in the evening under fasted conditions.
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On Day 2 of each 12-day treatment period
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Maximum Observed Plasma Concentration After Single Dose (Cmax)
Periodo de tiempo: On Day 2 of each 12-day treatment period
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elinzanetant administered in the evening under fasted conditions.
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On Day 2 of each 12-day treatment period
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- 22791
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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