Status:
COMPLETED
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Purpura, Thrombocytopaenic, Idiopathic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. The study i...
Eligibility Criteria
Inclusion
- Healthy or have renal impairment
- Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy
- Negative drug, alcohol, and HIV tests.
Exclusion
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing kidney function
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females who are pregnant or nursing
- Have active hepatitis B or C
Key Trial Info
Start Date :
September 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00442871
Start Date
September 28 2006
End Date
January 3 2008
Last Update
November 13 2017
Active Locations (2)
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1
GSK Investigational Site
Gainesville, Florida, United States, 32608
2
GSK Investigational Site
Saint Paul, Minnesota, United States, 55114-1067