A Study in Japanese Healthy Men to Test How Well Different Doses of BI 3031185 Are Tolerated and a Study in Japanese Healthy Women to Test Whether BI 3031185 Influences the Amount of a Contraceptive in the Blood
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)
Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose.
Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses.
Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Boehringer Ingelheim
- Número de teléfono: 1-800-243-0127
- Correo electrónico: clintriage.rdg@boehringer-ingelheim.com
Ubicaciones de estudio
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Fukuoka, Fukuoka, Japón, 813-0017
- Fukuoka Mirai Hospital
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Contacto:
- Boehringer Ingelheim
- Número de teléfono: 05050508862
- Correo electrónico: nippon@bitrialsupport.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
Single dose (SD) and multiple doses (MD) part: Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12- lead electrocardiogram (ECG), and clinical laboratory tests Oral contraceptives (OC) part: Women of non-childbearing potential (WONCBP) who meet postmenopausal or surgically sterilised according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
- Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- SD and MD part: Age of 18 to 45 years (inclusive) OC part: Age of 18 to 64 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 40 to 89 mmHg, or pulse rate outside the range of 45 to 99 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: SD part: BI 3031185
SD = Single dose
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BI 3031185
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Experimental: SD Part: Placebo matching BI 3031185
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Placebo matching BI 3031185
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Experimental: MD part: Midazolam and BI 3031185
MD = Multiple doses
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Midazolam
Otros nombres:
BI 3031185
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Experimental: MD Part: Midazolam and Placebo matching BI 3031185
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Midazolam
Otros nombres:
Placebo matching BI 3031185
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Experimental: OC part: YAZ® and BI 3031185
OC = Oral contraceptives
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BI 3031185
YAZ®
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Periodo de tiempo: Up to 29 days
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SD = Single dose
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Up to 29 days
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MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Periodo de tiempo: Up to 47 days
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MD = Multiple doses
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Up to 47 days
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OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Periodo de tiempo: Up to 29 days
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OC = Oral contraceptives
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Up to 29 days
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OC part: Maximum measured concentration of the analyte in plasma (Cmax)
Periodo de tiempo: Up to 29 days
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Up to 29 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Periodo de tiempo: Up to 11 days
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Up to 11 days
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SD part: Maximum measured concentration of the analyte in plasma (Cmax)
Periodo de tiempo: Up to 11 days
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Up to 11 days
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MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Periodo de tiempo: Up to 39 days
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Up to 39 days
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MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Periodo de tiempo: Up to 39 days
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Up to 39 days
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OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Periodo de tiempo: Up to 29 days
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Up to 29 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 1516-0005
- U1111-1331-6622 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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. .
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