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- Ensayo clínico NCT02170909
Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin
29 de agosto de 2018 actualizado por: Boehringer Ingelheim
Safety, Pharmacokinetics and Pharmacodynamics After Single (150 mg, 220 mg and 300 mg) and Multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) Rising Oral Doses of BIBR 1048 MS/Capsules in Healthy Male Subjects of Japanese and Caucasian Origin. (Open Label Study)
Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
Fase
- Fase 1
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
Healthy male subjects of Japanese or Caucasian origin according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, respiratory rate and tympanic body temperature), 12- lead ECG (electrocardiogram), clinical laboratory tests
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥ 20 and Age ≤ 45 years
- Body mass index (BMI) ≥ 18 and ≤ 25 kg/m2
- Japanese subjects were from a well-defined Japanese population, both parents of Japanese origin and the subjects have Japanese passport and had lived ≤ 8 years outside Japan.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Exclusion Criteria:
- Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman possibly become pregnant) from the time of the single dose on Day 1 until Day 22-26 (end-of study examination)
- Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
- History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
- Chronic or relevant acute infections
History of
- allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- any bleeding disorder including prolonged or habitual bleeding
- other hematologic disease
- cerebral bleeding (e.g. after a car accident)
- concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
- Use of acetylsalicylic acid (ASA)-containing over-the-counter medications, clopidogrel or ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs) (cyclooxygenase-2 (COX-2) inhibitors excluded), coumadin like anticoagulants, chronic use of corticosteroids, heparin and fibrinolytic agents within 14 days prior to administration or during the trial.
- Participation in another trial with an investigational drug within three months prior to administration or during the trial
- Smoker (> 10 cigarettes/day or > 3 cigars/day or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 21unit/week; one unit was approximately half a pint of beer, a small glass of wine or one measure of spirits)
- History of drug abuse
- Blood donation (more than 100 mL within three months prior to screening administration and any blood donation from screening to end-of-study examination)
- Excessive physical activities (within one week prior to administration or during the trial and until end-of-study examination)
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of study centre
- Known hypersensitivity to the drug or its excipients
- History of any familial bleeding disorder
- Thrombocytes < 150000/μL
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BIBR 1048 MS low dose
|
|
Experimental: BIBR 1048 MS medium dose
|
|
Experimental: BIBR 1048 MS high dose
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in vital signs
Periodo de tiempo: Baseline and up to day 26
|
Baseline and up to day 26
|
Change in 12-lead electrocardiogram (ECG)
Periodo de tiempo: Baseline and up to day 26
|
Baseline and up to day 26
|
Change in clinical laboratory tests
Periodo de tiempo: Baseline and up to day 26
|
Baseline and up to day 26
|
Occurence of adverse events
Periodo de tiempo: Up to day 26
|
Up to day 26
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Area under the curve (AUC) from 0-24 hours for activated partial thromboplastin time (aPTT)
Periodo de tiempo: Day 1 and 12
|
Day 1 and 12
|
AUC from 0-24 hours for ecarin clotting time (ECT)
Periodo de tiempo: Day 1 and 12
|
Day 1 and 12
|
Change in thrombin time (TT)
Periodo de tiempo: Baseline and up to 72 hours after administration on day 1 and 12
|
Baseline and up to 72 hours after administration on day 1 and 12
|
Change in prothrombin time (PT) expressed as international normalised ratio (INR)
Periodo de tiempo: Baseline and up to 72 hours after administration on day 1 and 12
|
Baseline and up to 72 hours after administration on day 1 and 12
|
Maximum value of aPTT
Periodo de tiempo: Up to 72 hours after administration on day 1 and 12
|
Up to 72 hours after administration on day 1 and 12
|
Maximum value of ECT
Periodo de tiempo: Up to 72 hours after administration on day 1 and 12
|
Up to 72 hours after administration on day 1 and 12
|
Change in ECT
Periodo de tiempo: Baseline and up to 72 hours after administration on day 1 and 12
|
Baseline and up to 72 hours after administration on day 1 and 12
|
Change in aPTT
Periodo de tiempo: Baseline and up to 72 hours after administration on day 1 and 12
|
Baseline and up to 72 hours after administration on day 1 and 12
|
Cmax (maximum measured concentration of the analyte in plasma)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the single dose on day 1)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
λz (terminal rate constant in plasma)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
t1/2 (terminal half-life of the analyte in plasma)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
MRTpo (mean residence time of the analyte in the body after po administration)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Periodo de tiempo: Up to 72 hours after administration on day 1
|
Up to 72 hours after administration on day 1
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
λz,ss (terminal rate constant in plasma at steady state)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
MRTpo,ss (mean residence time of the analyte in the body at steady state after po administration)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state)
Periodo de tiempo: Up to 72 hours after the last dose on day 12
|
Up to 72 hours after the last dose on day 12
|
Accumulation ratio RA,Cmax,7 based on Cmax
Periodo de tiempo: Day 6 to day 15
|
Day 6 to day 15
|
Accumulation ratio RA,AUC,7 based on AUCτ (only for 150 mg and 220 mg q.d. groups)
Periodo de tiempo: Day 6 to day 15
|
Day 6 to day 15
|
Linearity index (LI) based on AUC (only for 150 mg and 220 mg q.d. groups)
Periodo de tiempo: Day 6 to day 15
|
Day 6 to day 15
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2004
Finalización primaria (Actual)
1 de junio de 2005
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de junio de 2014
Publicado por primera vez (Estimar)
23 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
29 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1160.29
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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