Status:
COMPLETED
Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Vomiting
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy or have mild or moderate hepatic impairment
- Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
- Negative for Hepatitis B and C(healthy subjects)
- Negative drug, alcohol and HIV tests
- Exclusion criteria:
- Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
- Encephalopathy
- Active peptic ulcer disease
- Drug or alcohol abuse
- Pregnant or lactating
- Esophageal bleeding
- Heart failure
- Infection
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00359177
Start Date
December 1 2005
End Date
October 12 2006
Last Update
September 25 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Gainesville, Florida, United States, 32608
2
GSK Investigational Site
Orlando, Florida, United States, 32809