A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

September 7, 2017 updated by: GlaxoSmithKline

An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Balantonfured, Hungary, 8230
        • GSK Investigational Site
      • Budapest, Hungary, 1062
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GW406381 pharmacokinetic parameters AUC and Cmax
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2005

Primary Completion (Actual)

September 26, 2006

Study Completion (Actual)

September 26, 2006

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (Estimate)

September 7, 2006

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXA100754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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