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

21 septembre 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

24

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Florida
      • Gainesville, Florida, États-Unis, 32608
        • GSK Investigational Site
      • Orlando, Florida, États-Unis, 32809
        • GSK Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Healthy subjects receiving GW679769
Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.
Médicament: 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
Expérimental: Subjects with hepatic impairment receiving GW679769
Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.
Médicament: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Time to maximum observed concentration (tmax) of single oral dose of GW679769 in healthy subjects
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to Day 22
Laboratory assessment for urinalysis parameters pH, specific gravity, glucose, protein, ketones, and blood
Up to Day 22

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2005

Achèvement primaire (Réel)

12 octobre 2006

Achèvement de l'étude (Réel)

12 octobre 2006

Dates d'inscription aux études

Première soumission

28 juillet 2006

Première soumission répondant aux critères de contrôle qualité

28 juillet 2006

Première publication (Estimation)

1 août 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2017

Dernière vérification

1 septembre 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NKT102785

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Données/documents d'étude

  1. Formulaire de rapport de cas annoté
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan d'analyse statistique
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Spécification du jeu de données
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocole d'étude
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Rapport d'étude clinique
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulaire de consentement éclairé
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Ensemble de données de participant individuel
    Identifiant des informations: NKT102785
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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