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A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373243
First Posted: September 7, 2006
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Pain Drug: GW406381 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date: October 19, 2005
Study Completion Date: September 26, 2006
Primary Completion Date: September 26, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving GW406381
Subjects will receive single oral dose of 20 milligram (mg) of GW406381.
Drug: GW406381
GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00373243     History of Changes
Other Study ID Numbers: CXA100754
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
hepatic impairment pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases