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- Ensayo clínico NCT02053181
Study to Investigate the Pharmacokinetics and Safety of Cadazolid in Patients With Clostridium Difficile Infection
31 de enero de 2014 actualizado por: Actelion
A Phase 1, Open-label, Single Oral Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Cadazolid in Patients With Severe Clostridium Difficile Infection (CDI)
The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the quantity of cadazolid absorbed into the systemic circulation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
6
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Zagreb, Croacia, 1000
- Clinical Hospital for Infective Disease
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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
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Non-pregnant females were to remain non-pregnant for 1 month after the end of the study. Female subjects of child-bearing potential must have had a negative serum pregnancy test at screening and must have used a reliable method of contraception
- Subjects with severe CDAD; Clostridium difficile infection (CDI) must have been microbiologically proven, using a validated enzyme-linked immunosorbent assay (ELISA) for the detection of C. difficile toxin A (TcdA) and/or C. difficile toxin B (TcdB). The severity of CDAD was assessed according to the current European Union guidelines - European Society of Clinical Microbiology and Infectious Diseases (ESCMID).
- Received oral vancomycin or oral/intravenous (i.v.) metronidazole therapy for the treatment of CDAD.
- Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria:
- Known hypersensitivity to any excipients of the drug formulation.
- Clinical evidence of any relevant disease other than CDAD and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
- Subjects with rare hereditary fructose intolerance, glucose-galactose malabsorption, saccharase-isomaltase deficiency or previously undiagnosed diabetes mellitus.
- Subjects who have a life-threatening condition, which may be related to CDAD or other underlying illness.
- Any clinically relevant electrocardiogram (ECG) abnormality at screening.
- Subjects who were unable to swallow or have difficulty swallowing.
- Subjects with vomiting, ileus or not passing stool.
- Likelihood of death within 72 hours from any cause.
- Life-threatening or fulminant CDAD (White blood cell count > 30 × 10^9/L; temperature > 40 °C; or septic shock, peritoneal signs or significant dehydration).
- History of ulcerative colitis or Crohn's disease.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- Positive results from the human immunodeficiency virus (HIV) serology at screening.
- Legal incapacity or limited legal capacity at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cadazolid
Single oral dose of 3000 mg.
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Cadazolid was provided as dry powder for oral suspension (Amber glass bottles of 60 mL).
The powder was reconstituted with tap water by a pharmacist immediately prior to dispensing to subjects.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum plasma concentration (Cmax) of cadazolid
Periodo de tiempo: 144 hours
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Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing.
Cmax was calculated on the basis of the blood sampling time points.
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144 hours
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Time to reach maximum plasma concentration (tmax) of cadazolid
Periodo de tiempo: 144 hours
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Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing.
tmax was calculated on the basis of the blood sampling time points.
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144 hours
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Area under the plasma concentration-time curve (AUC(0-144h)) of cadazolid
Periodo de tiempo: 144 hours
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Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing.
AUC(0-144) was calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
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144 hours
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Unchanged cadazolid in urine up to Day 7
Periodo de tiempo: 144 hours
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Urine was collected into standard-weight polyethylene containers over the following time intervals: 0-12 h, 12-24 h, 24-36 h, 36-48 h, 48-72 h, 72-96 h, 96-120 h, and 120-144 h.
The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays.
The amount of drug excreted in the urine was obtained by multiplying the concentration of drug by the volume of matrix collected.
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144 hours
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Unchanged cadazolid in faeces up to Day 7
Periodo de tiempo: 144 hours
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Faeces were collected in pre-weighed polypropylene boxes.
The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays.
The amount of drug excreted in the faeces was obtained by multiplying the concentration of drug by the volume of matrix collected.
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144 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline up to Day 7 in systolic blood pressure (SBP)
Periodo de tiempo: 144 hours
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Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm).
Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
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144 hours
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Change from baseline up to Day 7 in diastolic blood pressure (DBP)
Periodo de tiempo: 144 hours
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Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm).
Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
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144 hours
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Change from baseline up to Day 7 in pulse rate
Periodo de tiempo: 144 hours
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Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm).
Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
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144 hours
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Change from baseline to Day 7 in body weight
Periodo de tiempo: 144 hours
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Body weight was measured using the same weighing scales.
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144 hours
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Change from baseline up to Day 7 in heart rate
Periodo de tiempo: 144 hours
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Heart rate was determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
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144 hours
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Change from baseline up to Day 7 in PQ interval (time interval from the beginning of the P wave to the beginning of the QRS complex)
Periodo de tiempo: 144 hours
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PQ interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
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144 hours
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Change from baseline up to Day 7 in QRS duration (time interval from the beginning of the Q wave to the end of the S wave)
Periodo de tiempo: 144 hours
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QRS duration was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
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144 hours
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Change from baseline up to Day 7 in QT (time interval from beginning of the Q wave until end of the T wave)
Periodo de tiempo: 144 hours
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QT interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
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144 hours
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Change from baseline up to Day 7 in QT interval according to Bazett's correction (QTcB)
Periodo de tiempo: 144 hours
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QTcB interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
The QTcB interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5
where RR is 60/heart rate)
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144 hours
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Change from baseline up to Day 7 in QT interval according to Fridericia's correction (QTcF)
Periodo de tiempo: 144 hours
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QTcF interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
The QTcF interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Fridericia's formula (QTcB = QT/RR^0.33
where RR is 60/heart rate)
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144 hours
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Frequency of treatment-emergent ECG abnormalities from up to Day 7
Periodo de tiempo: 144 hours
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Treatment-emergent abnormalities were determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
An ECG abnormality was considered treatment-emergent if it was not present during the screening period and/or at time of pre-dose assessment.
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144 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Alison Mackie, MSc, Actelion
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.
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 agosto de 2012
Finalización primaria (Actual)
1 de septiembre de 2012
Finalización del estudio (Actual)
1 de septiembre de 2012
Fechas de registro del estudio
Enviado por primera vez
30 de enero de 2014
Primero enviado que cumplió con los criterios de control de calidad
31 de enero de 2014
Publicado por primera vez (Estimar)
3 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
31 de enero de 2014
Última verificación
1 de enero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AC-061-103
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 Infección por Clostridium Difficile
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Gynuity Health ProjectsTerminadoClostridium sordellii | Clostridium perfringensEstados Unidos
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Hamilton Health Sciences CorporationReclutamientoDiarrea por Clostridium Difficile | Colonización por Clostridium difficileCanadá
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Microbiome Health Research InstituteBrown University; Tufts Medical Center; Indiana University; Edward HospitalTerminadoClostridium difficileEstados Unidos
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Seres Therapeutics, Inc.Syneos HealthTerminadoClostridium difficileEstados Unidos
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University of AlbertaTerminadoClostridium difficileCanadá
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McMaster UniversitySt. Joseph's Healthcare HamiltonTerminado
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Astellas Pharma Europe Ltd.Merck Sharp & Dohme LLCTerminadoClostridium difficileGrecia, España, Federación Rusa, Dinamarca, Austria, Bélgica, Croacia, Chequia, Finlandia, Francia, Alemania, Hungría, Irlanda, Italia, Polonia, Portugal, Rumania, Eslovenia, Suecia, Suiza, Pavo, Reino Unido
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University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...TerminadoClostridium difficileEstados Unidos
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PfizerTerminadoEnfermedad asociada a Clostridium difficileEstados Unidos
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PfizerTerminadoEnfermedad asociada a Clostridium difficileEstados Unidos
Ensayos clínicos sobre Cadazolid
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ActelionTerminadoInfección por Clostridium DifficileEstados Unidos, Australia, Brasil, Canadá, Francia, Alemania, Italia, Países Bajos, Perú, Polonia, Rumania, España
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ActelionTerminadoInfección por Clostridium DifficileEstados Unidos, Bélgica, Israel, Argentina, Brasil, Canadá, Chile, Croacia, Chequia, Grecia, Hungría, Corea, república de, Rumania, Eslovaquia
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ActelionTerminadoInfección por Clostridium DifficileEstados Unidos, Canadá, Alemania, Italia, Suecia, Reino Unido
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ActelionTerminadoInfección por Clostridium DifficileEstados Unidos, Bélgica, Canadá, Chequia, Hungría, Italia, Polonia, Rumania, España