A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00373243
First received: September 5, 2006
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.


Condition Intervention Phase
Hepatic Insufficiency
Drug: GW406381
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • GW406381 pharmacokinetic parameters AUC and Cmax [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG [ Time Frame: throughout the study ]

Enrollment: 24
Study Start Date: October 2005
Intervention Details:
    Drug: GW406381
    Other Name: GW406381
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
  • Body weight less = 100 kg
  • Body mass index (BMI) within range of 19 - 32 32kg/m2

Exclusion criteria:

  • Presence of any other significant disease
  • Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373243

Locations
Hungary
GSK Investigational Site
Balantonfured, Hungary, 8230
GSK Investigational Site
Budapest, Hungary, 1062
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00373243     History of Changes
Other Study ID Numbers: CXA100754
Study First Received: September 5, 2006
Last Updated: May 15, 2009
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by GlaxoSmithKline:
hepatic impairment pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014