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- Ensayo clínico NCT02171806
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers
20 de junio de 2014 actualizado por: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2.5 μg, 10 μg, and 30 μg) of BI 1744 CL for 14 Days in Healthy Male and Female Volunteers (Doubleblind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
47
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
21 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male or female based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 60 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute).
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 2 months after release from the study.
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
|
|
Experimental: BI 1744 CL multiple rising doses
|
|
Experimental: BI 1744 CL medium dose, females
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of patients with clinically significant changes in physical examination
Periodo de tiempo: Baseline, day 32 (end-of-study examination)
|
Baseline, day 32 (end-of-study examination)
|
Number of patients with clinically significant changes in vital signs
Periodo de tiempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram)
Periodo de tiempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with abnormal changes in laboratory tests
Periodo de tiempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in airway resistance (Raw) measured by body plethysmography
Periodo de tiempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in tremormetry parameters
Periodo de tiempo: Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with adverse events
Periodo de tiempo: Up to day 32
|
Up to day 32
|
Assessment of tolerability by the investigator on a 4-point scale
Periodo de tiempo: Day 32 (end-of-study examination)
|
Day 32 (end-of-study examination)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
tmax (time from dosing to maximum concentration)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Periodo de tiempo: Up to 384 hours after drug administration
|
Up to 384 hours after drug administration
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Periodo de tiempo: Up to 384 hours after drug administration
|
Up to 384 hours after drug administration
|
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
λz (terminal rate constant of the analyte in plasma)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
t½ (terminal half-life of the analyte in plasma)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
MRTih (mean residence time of the analyte in the body after inhalation)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,AUC,14 based on AUC0-τ
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Linearity Index (LI)
Periodo de tiempo: Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
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 enero de 2006
Finalización primaria (Actual)
1 de septiembre de 2006
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)
24 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
20 de junio de 2014
Última verificación
1 de junio de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1222.2
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. .