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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 23, 2014