Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects (PK of TDF)
An Open-label Single and Repeat Dose Study to Investigate the Pharmacokinetic Profiles of Tenofovir Disoproxil Fumarate 300 mg in Healthy Chinese Subjects
Descripción general del estudio
Descripción detallada
This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, single and repeat dose sessions and a follow-up contact.
The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.
Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.
The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.
Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.
Subjects completing the dosing sessions will not be required to visit the study centre for a follow-up visit, unless the Investigator determines that it is necessary for safety or other reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the last dosing to collect any information on concomitant medication taken and AEs experienced since the last visit.
The total duration of each subject's participation, from screening to follow-up contact, will be approximately 7 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Shanghai, Porcelana, 200030
- GSK Investigational Site
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy, as determined by a responsible and experienced physician
- Male or female between 18 and 45 years of age
- Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2
Exclusion Criteria:
- Positive result for hepatitis B, hepatitis C or HIV at screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Positive urine drug screen and breath alcohol test at screening or prior to dosing
- Lactating females
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TDF tablets
Tenofovir disoproxil fumarate tablets
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White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
Periodo de tiempo: up to 60 hours after single dose
|
AUC(0-t) of single dose
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up to 60 hours after single dose
|
|
area under the concentration-time curve during steady state (AUC(0-τ))
Periodo de tiempo: up to 60 hours after repeat dose
|
AUC(0-τ) during steady state
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up to 60 hours after repeat dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
adverse events (AEs)
Periodo de tiempo: up to 20 days, from the first dose until the follow-up contact
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AEs accur during the study
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up to 20 days, from the first dose until the follow-up contact
|
|
vital signs
Periodo de tiempo: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
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blood pressure, pulse rate, respiratory rate and temperature
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day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
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lab assessment
Periodo de tiempo: day 13, prior to discharge from hospital
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Haematology, Clinical Chemistry and Routine Urinalysis
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day 13, prior to discharge from hospital
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12-lead electrocardiogram (ECG) parameters
Periodo de tiempo: day 13, prior to discharge from hospital
|
the heart rate and measures PR, QRS, QT and QTc intervals.
All ECGs must be evaluated for safety by a qualified physician.
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day 13, prior to discharge from hospital
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Hepatitis Crónica
- Hepatitis B
- Hepatitis
- Hepatitis B Crónica
Otros números de identificación del estudio
- 115515
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