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Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

21 de septiembre de 2017 actualizado por: GlaxoSmithKline

An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Hepatic Impairment

The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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

  • Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos, 32608
        • GSK Investigational Site
      • Orlando, Florida, Estados Unidos, 32809
        • GSK Investigational Site

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 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • Healthy or have mild or moderate hepatic impairment
  • Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
  • Negative for Hepatitis B and C(healthy subjects)
  • Negative drug, alcohol and HIV tests

Exclusion criteria:

  • Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
  • Encephalopathy
  • Active peptic ulcer disease
  • Drug or alcohol abuse
  • Pregnant or lactating
  • Esophageal bleeding
  • Heart failure
  • Infection

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Healthy subjects receiving GW679769
Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.
Droga: GW679769
GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning
Experimental: Subjects with hepatic impairment receiving GW679769
Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.
Droga: GW679769
GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for pharmacokinetics (PK) analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
AUC of multiple oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Cmax of multiple oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
AUC of single oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
AUC of multiple oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Cmax of single oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Cmax of multiple oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to maximum observed concentration (tmax) of single oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
tmax of multiple oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
tmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
tmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
tmax of single oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
tmax of multiple oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
tmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
tmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Terminal half-life (t1/2) of single oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of multiple oral dose of GW679769 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
t1/2 of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
t1/2 of single oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of multiple oral dose of GSK525060 in healthy subjects
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data.
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
t1/2 of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours
t1/2 of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Periodo de tiempo: Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Percentage of unbound GW679769 in healthy subjects receiving single oral dose of GW679769
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GW679769 in healthy subjects receiving multiple oral dose of GW679769
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data
1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving single oral dose of GW679769
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GW679769
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GSK525060 in healthy subjects receiving single oral dose of GSK525060
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GSK525060 in healthy subjects receiving multiple oral dose of GSK525060
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving single oral dose of GSK525060
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1
Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GSK525060
Periodo de tiempo: 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data.
1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose
Number of subjects with Adverse events (AE) and Serious AEs (SAE)
Periodo de tiempo: Up to Day 22
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent disability/incapacity, or may led to any congenital anomaly or birth defect
Up to Day 22
Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Periodo de tiempo: Up to Day 22
Blood pressure measurement will be assessed in supine and resting position.
Up to Day 22
Number of subjects with abnormal heart rate
Periodo de tiempo: Up to Day 22
Blood pressure measurement will be assessed in supine and resting position.
Up to Day 22
Number of subjects with abnormal hematology parameters
Periodo de tiempo: Up to Day 22
Laboratory assessment for hematology parameters will include hemoglobin, hematocrit, red blood cell count (RBC), platelet count, white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, prothrombin time (PT), and International Normalized Ratio (INR)
Up to Day 22
Number of subjects with abnormal clinical chemistry parameters
Periodo de tiempo: Up to Day 22
Laboratory assessment for clinical chemistry parameters sodium, potassium, chloride, total Carbon dioxide, calcium, glucose (fasting), phosphorous (inorganic), protein (total), albumin, gamma-glutamyl-transferase (GGT), bilirubin (total), alkaline Phosphatase, lactic dehydrogenase (LDH), aspartate aminotransferase (AST; Serum glutamic oxaloacetic transaminase), alanine aminotransferase (ALT; Serum glutamic pyruvic transaminase), creatinine, blood Urea Nitrogen, uric Acid, creatine Phosphokinase (CPK), and ammonia
Up to Day 22
Number of subjects with abnormal urinalysis
Periodo de tiempo: Up to Day 22
Laboratory assessment for urinalysis parameters pH, specific gravity, glucose, protein, ketones, and blood
Up to Day 22

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

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 (Actual)

1 de diciembre de 2005

Finalización primaria (Actual)

12 de octubre de 2006

Finalización del estudio (Actual)

12 de octubre de 2006

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2006

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2006

Publicado por primera vez (Estimar)

1 de agosto de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2017

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NKT102785

Plan de datos de participantes individuales (IPD)

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Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Formulario de informe de caso anotado
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan de Análisis Estadístico
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Especificación del conjunto de datos
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocolo de estudio
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informe de estudio clínico
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulario de consentimiento informado
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Conjunto de datos de participantes individuales
    Identificador de información: NKT102785
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

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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