Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
- Registration Number
- NCT00442871
- Lead Sponsor
- GlaxoSmithKline
- 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 is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eltrombopag eltrombopag Eltrombopag 50 mg oral (single dose)
- Primary Outcome Measures
Name Time Method Plasma levels and protein binding of eltrombopag at Day 1 to Day 6. plasma levels/protein binding for eltrombopag
- Secondary Outcome Measures
Name Time Method adverse assessment Day 1 to followup Adverse event review
clinical labs, vital signs, & 12-lead electrocardiograms done all days but Day 4 Clinical labs, vital signs and 12 lead electrocardiograms
Safety will be assessed by: -eye exam at Screening, Day -1, & followup eye exam safety findings
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Saint Paul, Minnesota, United States