TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study
10 de octubre de 2012 actualizado por: Tibotec Pharmaceuticals, Ireland
A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations
The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules.
After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal.
This will be done in healthy volunteers.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers.
Crossover means that participants may receive different interventions sequentially during the trial.
Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin.
Open-label means that you and your physician will know what treatment you will receive.
The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase.
Total study duration for an individual participant will be up to 6 or 7 weeks.
Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase.
In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance.
Treatment A is a single dose of TMC345 as one formulation (1 capsule).
Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule).
Both treatments will be taken without food.
In between the 2 sessions, there will be at least 7 days.
In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance.
All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part.
In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast.
In between the sessions, there will be at least 7 days.
For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after.
The 3 following mornings, participants will come back to the study center.
Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase).
During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug).
In every treatment session, a single oral 150 mg TMC435 capsule will be given.
One formulation will be a gelatin capsule.
The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.
Tipo de estudio
Intervencionista
Inscripción (Actual)
48
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 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Non-smokers for at least 3 months prior to screening
- Have a body mass index of 18.0 to 30.0 kg per square meter
- Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Exclusion Criteria:
- Use of disallowed therapies, including over-the-counter products and dietary supplements
- Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
- Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
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 cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 001
TMC435 gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimental: 002
TMC435 HPMC capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimental: 003
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimental: 004
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimental: 005
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Periodo de tiempo: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
|
Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state
Periodo de tiempo: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of participants with adverse events and the severity of adverse events
Periodo de tiempo: During maximum 7 weeks
|
During maximum 7 weeks
|
|
Percentage of abnormal values for laboratory parameters
Periodo de tiempo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Observed values and changes from baseline of cardiovascular variables
Periodo de tiempo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Periodo de tiempo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Physical examination findings and changes from baseline.
Periodo de tiempo: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 2011
Finalización del estudio (Actual)
1 de junio de 2011
Fechas de registro del estudio
Enviado por primera vez
3 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
3 de marzo de 2011
Publicado por primera vez (Estimar)
4 de marzo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de octubre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
10 de octubre de 2012
Última verificación
1 de octubre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Hepatitis
- Hepatitis C
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Simeprevir
Otros números de identificación del estudio
- CR015940
- TMC435-TiDP16-C116
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