Status:
COMPLETED
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Vomiting
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate how subjects with mild or moderate kidney 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 renal impairment.
- Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner).
- Be negative for Hepatitis B and C.
- Have negative results on drug, alcohol and HIV tests.
- Have stable renal function.
- Exclusion criteria:
- Have a peptic ulcer.
- Abuse drugs or alcohol.
- Are pregnant or lactating.
- Have heart failure.
- Have uncontrolled emesis.
- Have an infection.
- Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start.
- Active peptic ulcer disease.
- Digoxin use.
- Laboratory results that show low iron or pepsinogen levels, AST and CK level \>1,5 ULN, or that show stool is positive for occult blood.
Exclusion
Key Trial Info
Start Date :
September 8 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00358813
Start Date
September 8 2006
End Date
August 22 2008
Last Update
August 4 2017
Active Locations (3)
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1
GSK Investigational Site
Miramar, Florida, United States, 33025
2
GSK Investigational Site
Orlando, Florida, United States, 32809
3
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404