Status:
COMPLETED
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 impa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00373243
Start Date
October 19 2005
End Date
September 26 2006
Last Update
September 11 2017
Active Locations (2)
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1
GSK Investigational Site
Balantonfured, Hungary, 8230
2
GSK Investigational Site
Budapest, Hungary, 1062