- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03747926
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 705564 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.
A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.
Descripción general del estudio
Tipo de estudio
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR), body temperature), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age of 20 to 50 years (incl.) at screening
- Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (incl.) at screening
- Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Male subject who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after the trial completion:
Use of adequate contraception, e.g., any of the following methods plus condom:
--- combined oral contraceptives, intrauterine device.
- Vasectomised (vasectomy at least 1 year prior to enrolment)
- Surgical sterilised (including hysterectomy) of the subject's female partner
Exclusion criteria:
- Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 45 to 90 beats per minute (bpm) at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders, including but not limited to mood disorders and any history of suicidality
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections including human immunodeficiency virus (HIV), viral hepatitis, syphilis and/or tuberculosis or evidence of tuberculosis infection as defined by positive QuantiFERON TB-Gold (or T-SPOT) test. (Subject with positive Hepatitis B core antibody will not allowed to participate in this study)
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Use of drugs within 30 days or 5 half-lives, whichever is longer prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 30 g per day)
- Drug abuse or positive drug screening
- Blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 msecond) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Subjects who, in the investigator's judgement, are perceived as having an increased risk of bleeding, e.g., history of haemorrhagic disorders, clinical relevant petechial bleeding, occult blood in faeces, haematuria in repeated urine tests, trauma or surgery within the last month, planned surgery during trial participation, history of arteriovenous malformation or aneurysm, history of gastroduodenal ulcer disease or gastrointestinal haemorrhage, history of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding, use of drugs that may interfere with haemostasis during trial conduct (e.g., acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)
- Repeated absolute B cell (CD19+) counts below 40/μL at screening
- Repeated platelet counts below 100 cells/nL (10.0×104/μL) at screening
- Serum potassium below normal range at screening
- A history or current clinical signs of acute pancreatitis
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 |
---|---|
Comparador de placebos: Placebo
|
single-rising oral dose
|
Experimental: BI 705564
|
single-rising oral dose
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number [N (%)] of subjects with drug-related Adverse Events (AEs)
Periodo de tiempo: Up to day 7
|
Up to day 7
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
AUC0-∞ (área bajo la curva de concentración-tiempo del analito en plasma durante el intervalo de tiempo de 0 extrapolado al infinito)
Periodo de tiempo: Hasta 72 horas
|
Hasta 72 horas
|
Cmax (concentración máxima medida del analito en plasma)
Periodo de tiempo: Hasta 72 horas
|
Hasta 72 horas
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 1408-0005
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, except for the following exclusions:
- 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 (because of limitations with anonymization).
For more details refer to: 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. .
Ensayos clínicos sobre BI 705564
-
Boehringer IngelheimRetiradoLupus Eritematoso Sistémico
-
Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado
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Boehringer IngelheimReclutamientoMelanoma | Cáncer de pulmón de células no pequeñas (CPCNP) | Carcinoma de células escamosas de cabeza y cuello (HNSCC)Países Bajos
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Boehringer IngelheimAún no reclutando
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Boehringer IngelheimReclutamientoTumores sólidosHungría
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminadoSaludablePaíses Bajos