Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
13 de octubre de 2014 actualizado por: Boehringer Ingelheim
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 Healthy Male Volunteers
- To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers
- To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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
50 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- 50 to 65 years of age
- Body Mass Index (BMI) of 19.9 to 29.9 kg/m2
- Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm
- All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Exclusion Criteria:
- Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders
- Diseases of the central nervous system or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, 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
- Intake of drugs with a long half-life (> 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within 2 months prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range and of clinical relevance
- Inability to comply with dietary regimen of study centre
Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the drugs under study or for the study:
- Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
- ECG: PR interval > 210 ms
- HR at rest ≤ 55 beats per minute (bpm)
- Relevant ophthalmological disease
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: [14C]-DK-AH 269 CL intravenous
|
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Experimental: [14C]-DK-AH 269 CL oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum measured concentration of the analytes in plasma (Cmax)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
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Area under the concentration-time curve of the analytes in plasma (AUC)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Terminal rate constant of the analytes in plasma (λz)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Terminal half-life of the analytes in plasma (t1/2)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Mean residence time of the analytes in the body after intravenous administration (MRT)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Mean residence time of the analytes in the body after oral administration (MRTpo)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Total clearance of the analytes in plasma following intravascular administration (CL)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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|
Volume of distribution at steady state (Vss)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
Periodo de tiempo: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
|
|
Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
Periodo de tiempo: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
|
|
Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
Periodo de tiempo: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
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|
Fraction of dose absorbed, based on radioactivity data (Fa)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Absolute bioavailability of the analytes after oral administration (F)
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Ratio of CBlood cells/Cplasma [14C]-radioactivity
Periodo de tiempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
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|
Number of patients with clinically significant findings in vital signs
Periodo de tiempo: up to 12 days after last drug administration
|
blood pressure, heart rate
|
up to 12 days after last drug administration
|
|
Number of patients with clinically significant findings in 12-lead ECG
Periodo de tiempo: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
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Number of patients with clinically significant findings in 2-lead ECG (telemetry)
Periodo de tiempo: up to 90 minutes after start of treatment
|
up to 90 minutes after start of treatment
|
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Clinically significant changes from baseline in physical examination
Periodo de tiempo: Pre-dose, and 12 days after last drug administration
|
Pre-dose, and 12 days after last drug administration
|
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Occurrence of visual phenomena
Periodo de tiempo: up to 120 hours after start of treatment
|
questionnaire
|
up to 120 hours after start of treatment
|
|
Number of patients with clinically significant findings in clinical laboratory tests
Periodo de tiempo: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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 marzo de 2004
Finalización primaria (Actual)
1 de abril de 2004
Fechas de registro del estudio
Enviado por primera vez
13 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
13 de octubre de 2014
Publicado por primera vez (Estimar)
15 de octubre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
15 de octubre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
13 de octubre de 2014
Última verificación
1 de octubre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 503.209
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. .