Un estudio en hombres sanos para probar qué tan bien se toleran las diferentes dosis de BI 1569912 y cómo los alimentos influyen en la cantidad de BI 1569912 en la sangre
Seguridad, tolerabilidad, farmacocinética y farmacodinámica de dosis orales únicas crecientes de BI 1569912 en sujetos masculinos sanos (simple ciego, parcialmente aleatorizado dentro de grupos de dosis, controlado con placebo, diseño de grupos paralelos) con una parte adicional de biodisponibilidad relativa/efecto alimentario (abierto -etiqueta, aleatorizado, diseño cruzado de tres vías)
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Charité - Universitätsmedizin Berlin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Sujetos masculinos sanos según la evaluación del investigador, basada en un historial médico completo que incluye un examen físico, signos vitales (presión arterial (PA), frecuencia del pulso (PR), frecuencia respiratoria (RR), temperatura (T)), ECG de 12 derivaciones y pruebas de laboratorio clínico
- Edad de 18 a 45 años (inclusive)
- IMC de 18,5 a 29,9 kg/m2 (inclusive)
- Consentimiento informado por escrito firmado y fechado antes de la admisión al estudio, de acuerdo con las BPC y la legislación local
Sujetos masculinos que cumplan cualquiera de los siguientes criterios desde al menos 30 días antes de la primera administración de la medicación del ensayo hasta 30 días después de la finalización del ensayo:
- Uso de métodos anticonceptivos adecuados, p. cualquiera de los siguientes métodos (de parejas femeninas) más condón: implantes, inyectables, anticonceptivos orales o vaginales combinados, dispositivo intrauterino
- Abstinencia sexual
- Esterilizado quirúrgicamente (incluida la histerectomía de la pareja femenina)
- Pareja femenina posmenopáusica, definida como al menos 1 año de amenorrea espontánea (en casos cuestionables, una muestra de sangre con hormona estimulante del folículo (FSH) por encima de 40 U/L y estradiol por debajo de 30 ng/L es confirmatoria)
Criterio de exclusión:
- Cualquier hallazgo en el examen médico (incluidos BP, PR o ECG) que se desvíe de lo normal y sea evaluado como clínicamente relevante por el investigador
- Medición repetida de presión arterial sistólica fuera del rango de 90 a 140 mmHg, presión arterial diastólica fuera del rango de 50 a 90 mmHg o frecuencia del pulso fuera del rango de 50 a 90 lpm
- Cualquier valor de laboratorio fuera del rango de referencia que el investigador considere de relevancia clínica, en particular, parámetros hepáticos (alanina aminotransferasa (ALT), aspartato aminotransferasa (AST), bilirrubina total) o parámetros renales (creatinina) que excedan el límite superior de la normalidad. (ULN) después de mediciones repetidas
- Cualquier evidencia de una enfermedad concomitante evaluada como clínicamente relevante por el investigador
- Trastornos gastrointestinales, hepáticos, renales, respiratorios, cardiovasculares, metabólicos, inmunológicos u hormonales
- Colecistectomía u otra cirugía del tracto gastrointestinal que podría interferir con la farmacocinética del medicamento del ensayo (excepto apendicectomía o reparación simple de hernia)
- Historial de hipotensión ortostática relevante, episodios de desmayo o desmayos inexplicables
- Infecciones crónicas o agudas relevantes
- Una prueba de reacción en cadena de la polimerasa (PCR) positiva para SARS-CoV-2/COVID-19 y/o cualquier síntoma clínico que sugiera esta enfermedad en la selección y en el Día -3.
Se aplican otros criterios de exclusión.
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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Comparador de placebos: SRD part: Placebo
This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. |
Placebo
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Experimental: SRD part: 0.25mg BI 1569912
Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 0.75mg BI 1569912
Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 2.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 5.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 10.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 20.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: SRD part: 30.0 mg BI 1569912
Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
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BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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Experimental: BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted
Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. |
BI 1569912
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)
Periodo de tiempo: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
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Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator. |
From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
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BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Periodo de tiempo: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Periodo de tiempo: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Periodo de tiempo: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Periodo de tiempo: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
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BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Periodo de tiempo: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
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Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
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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 (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 1447-0001
- 2019-004836-51 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Los estudios clínicos patrocinados por Boehringer Ingelheim, fases I a IV, intervencionistas y no intervencionistas, están dentro del alcance para compartir los datos sin procesar del estudio clínico y los documentos del estudio clínico, excepto por las siguientes exclusiones:
1. estudios en productos en los que Boehringer Ingelheim no sea el titular de la licencia; 2. estudios sobre formulaciones farmacéuticas y métodos analíticos asociados, y estudios pertinentes a la farmacocinética usando biomateriales humanos; 3. estudios realizados en un solo centro o dirigidos a enfermedades raras (debido a las limitaciones con la anonimización).
Para obtener más detalles, consulte: https://www.mystudywindow.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. .