- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07722585
A Study to Learn About How a New Nurandociguat Tablet is Absorbed and Processed in the Body Compared to an Old Tablet and How Food Affects the Way the New Tablet is Absorbed and Processed in the Body
A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation
Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.
The main purposes of the study are
- To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as "pharmacokinetics [PK]" measurement) compared to an old tablet when taken without food.
- To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).
To do this, researchers will take blood samples from the participants and measure:
- Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma
- Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.
Only healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:
- Treatment A: Nurandociguat old tablet, taken without food
- Treatment B: Nurandociguat new tablet, taken without food
- Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.
- For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.
- The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).
The researchers will closely monitor and manage any medical problems that the participants may have during the study.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: 0018888422937
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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Berlin, Alemania, 13627
- Reclutamiento
- CRS Clinical Research Services Berlin GMBH
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participant must be 18 to 58 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.
- Body Mass Index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight above or equal 60 kg.
- Male and female.
Exclusion Criteria:
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines within the last 14 days before the first study intervention administration.
- Special diets preventing the participants from eating the standard meals during the study.
- Participant is unable or unwilling to comply with study restrictions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Optional Scheme 1-3: Treatment A-B-C
Treatment A: Single dose of nurandociguat old tablet taken without food.
Treatment B: Single dose of nurandociguat new tablet taken without food.
Treatment C: Single dose of nurandociguat new tablet taken with food.
Wash-out between treatments will be at least 7 days after last study drug administration.
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Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
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Experimental: Optional Scheme 1-3: Treatment A-C-B
Treatment A: Single dose of nurandociguat old tablet taken without food.
Treatment C: Single dose of nurandociguat new tablet taken with food.
Treatment B: Single dose of nurandociguat new tablet taken without food.
Wash-out between treatments will be at least 7 days after last study drug administration.
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Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
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Experimental: Optional Scheme 1-3: Treatment B-A-C
Treatment B: Single dose of nurandociguat new tablet taken without food.
Treatment A: Single dose of nurandociguat old tablet taken without food.
Treatment C: Single dose of nurandociguat new tablet taken with food.
Wash-out between treatments will be at least 7 days after last study drug administration.
|
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
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Experimental: Optional Scheme 1-3: Treatment B-C-A
Treatment B: Single dose of nurandociguat new tablet taken without food.
Treatment C: Single dose of nurandociguat new tablet taken with food.
Treatment A: Single dose of nurandociguat old tablet taken without food.
Wash-out between treatments will be at least 7 days after last study drug administration.
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Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
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Experimental: Optional Scheme 1-3: Treatment C-A-B
Treatment C: Single dose of nurandociguat new tablet taken with food.
Treatment A: Single dose of nurandociguat old tablet taken without food.
Treatment B: Single dose of nurandociguat new tablet taken without food.
Wash-out between treatments will be at least 7 days after last study drug administration.
|
Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
|
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Experimental: Optional Scheme 1-3: Treatment C-B-A
Treatment C: Single dose of nurandociguat new tablet taken with food.
Treatment B: Single dose of nurandociguat new tablet taken without food.
Treatment A: Single dose of nurandociguat old tablet taken without food.
Wash-out between treatments will be at least 7 days after last study drug administration.
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Single dose (SD) in treatment A.
Single dose (SD) in treatment B and C.
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Experimental: Optional Scheme 4-5
Participants will receive nurandociguat new tablet for 7 days at a lower starting dose.
Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days).
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High dose once daily for 5 days.
Low dose once daily for 7 days, high dose once daily for 6 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Optional scheme 1-3 - Cmax for nurandociguat
Periodo de tiempo: 0-72 hours post dose
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Cmax=Maximum observed concentration
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0-72 hours post dose
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Optional scheme 1-3 - AUC for nurandociguat
Periodo de tiempo: 0-72 hours post dose
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AUC=Area under the concentration time curve
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0-72 hours post dose
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Optional scheme 4 and 5 - Cmax,md for nurandociguat
Periodo de tiempo: 0-24 hours post dose
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Cmax,md=Cmax after multiple dosing
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0-24 hours post dose
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Optional scheme 4 and 5 - AUCt,md for nurandociguat
Periodo de tiempo: 0-24 hours post dose
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AUCt,md=AUC after multiple dosing.
t (Tau)=24 hours.
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0-24 hours post dose
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of participants with treatment-emergent adverse events (TEAEs)
Periodo de tiempo: From the first dose of study intervention up to 7 days after end of treatment with study intervention
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From the first dose of study intervention up to 7 days after end of treatment with study intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- 22700
- 2025-524176-36-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .