- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02251145
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
25 de septiembre de 2014 actualizado por: Boehringer Ingelheim
A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers
Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the pharmacokinetics of tipranavir/ritonavir.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
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
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Ability and willingness to give written informed consent in accordance with institutional and regulatory guidelines and to comply with the investigational nature of the study and the related requirements
- Healthy males or females between 18 and 60 years of age inclusive
- A Body Mass Index >18.5 and <30 kg/m2
- Ability to swallow numerous large capsules without difficulty
- Reasonable probability for completion of the study, in the opinion of the investigator
- Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity <= Grade1 based on the AIDS Clinical Trials Group (ACTG) Division of AIDS (DAIDS) Grading Scale. All abnormal laboratory values > Grade 1 (e.g., creatine phosphokinase (CPK), amylase, triglycerides) are subject to approval by the BIPI clinical monitor. Cholesterol <= 240mg/dL at the time of screening is necessary for study entry
- Acceptable medical history, physical examination and ECG are required prior to entering the study
- Willingness to abstain from alcohol for 48 hours prior to Study Day 0 and abstain from alcohol for the duration of the study. In addition, Cabernet Sauvignon must not have been ingested within 15 days prior to Day 0 (Visit 2)
- Willingness to abstain from ingesting grapefruit and grapefruit juice within 15 days of Day 0, Visit 2 and for the duration of the study
- Willingness to abstain from ingesting Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of pharmacokinetic (PK) sampling days
- Willingness to abstain from use of tobacco products for the duration of the study
- Urine drug screen negative for illegal non-prescription drugs
- Negative HIV serology
- Negative for Hepatitis B surface antigen and Hepatitis C
Exclusion Criteria:
Female subjects who are of reproductive potential who:
- Have a positive serum B-HCG at Visit 1 or 2 or
- Have not been using regular oral contraception (combined oestrogen and progestogen pill or progestogen only pill) for 3 months and a barrier contraceptive method for at least 30 days prior to Visit 3 (Day 1) or a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1) or
- Are not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam)during the trial and 30 days after completion/termination or
- Are breast-feeding
- Participation in another trial with an investigational medicine for 30 days prior to Day 0 (Visit 2)
- Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications) for 30 days prior to Day 0 (Visit 2). Use of any other herbal/complementary treatment must be discussed in advance with the monitor and permission obtained prior to study entry
- Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within 15 days prior to Day 0 (Visit 2)
- Ingestion of Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of PK sampling days
- Ingestion of antibiotics within 10 days prior to Day 0 (Visit 2)
- Inability to comply with investigator's instructions
- History of gastrointestinal, hepatic, or renal disorders within 60 days
- History of alcohol abuse
- Current use of cigarettes defined as greater than 10 cigarettes per day or rolling/pipe tobacco equivalent
- Blood or plasma donations within 30 days prior to Day 0 (Visit 2)
- Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >100 beats/min
- Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir or ritonavir or tenofovir disoproxil fumarate to the subject
- Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
- Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0, (Visit 2) or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the clinical monitor and pharmacokineticist, might interfere with either the absorption, distribution or metabolism of the test substances
- Hypersensitivity to tipranavir, ritonavir, or tenofovir disoproxil fumarate
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 |
---|---|
Experimental: tipranavir/ritonavir low dose
|
|
Experimental: tipranavir/ritonavir high dose
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Area under plasma concentration time curve from 0-12hours (AUC0-12) for tipranavir/ritonavir
Periodo de tiempo: up to 12 hours
|
up to 12 hours
|
Maximum plasma concentration (Cmax)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tenofovir
Periodo de tiempo: up to 12 hours
|
up to 12 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tipranavir/ritonavir
Periodo de tiempo: up to 12 hours
|
up to 12 hours
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Concentración plasmática máxima en estado estacionario (Cmax,ss)
Periodo de tiempo: hasta 24 horas
|
hasta 24 horas
|
Trough plasma concentration at steady state (Cmin)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Mean residency time (MRT)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Apparent terminal half life (T1/2)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Time of maximum concentration (Tmax)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Oral clearance (CL/F)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Periodo de tiempo: up to 24 hours
|
up to 24 hours
|
Number of subjects with clinically significant findings in vital signs (pulse rate, blood pressure)
Periodo de tiempo: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in physical examination
Periodo de tiempo: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in electrocardiogram
Periodo de tiempo: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in laboratory tests
Periodo de tiempo: up to 14 days
|
up to 14 days
|
Number of subjects with adverse events
Periodo de tiempo: up to 14 days
|
up to 14 days
|
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 mayo de 2002
Finalización primaria (Actual)
1 de junio de 2002
Fechas de registro del estudio
Enviado por primera vez
25 de septiembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
25 de septiembre de 2014
Publicado por primera vez (Estimar)
29 de septiembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de septiembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
25 de septiembre de 2014
Última verificación
1 de septiembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Tenofovir
- Ritonavir
- Tipranavir
Otros números de identificación del estudio
- 1182.46
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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