A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment
1 other identifier
interventional
24
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pain
Started Oct 2005
Typical duration for phase_1 pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2005
CompletedFirst Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2006
CompletedSeptember 11, 2017
September 1, 2017
11 months
September 5, 2006
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GW406381 pharmacokinetic parameters AUC and Cmax
throughout the study
Secondary Outcomes (1)
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
throughout the study
Study Arms (1)
Subjects receiving GW406381
EXPERIMENTALSubjects will receive single oral dose of 20 milligram (mg) of GW406381.
Interventions
GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Balantonfured, 8230, Hungary
GSK Investigational Site
Budapest, 1062, Hungary
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
October 19, 2005
Primary Completion
September 26, 2006
Study Completion
September 26, 2006
Last Updated
September 11, 2017
Record last verified: 2017-09