Status:
COMPLETED
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
Lead Sponsor:
GlaxoSmithKline
Conditions:
Purpura, Thrombocytopaenic, Idiopathic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy or have liver 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.
- Body mass index (BMI-within acceptable range)
- Negative drug, alcohol, and HIV tests
- Exclusion criteria:
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing liver function
- Kidneys not working well
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females that are pregnant or nursing
- Have active hepatitis B or C
- History of blood disorders
- History of various heart conditions (as noted by study doctor)
- Blood clotting problems or blood abnormalities
Exclusion
Key Trial Info
Start Date :
April 18 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00359463
Start Date
April 18 2006
End Date
March 7 2007
Last Update
November 13 2017
Active Locations (5)
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1
GSK Investigational Site
Gainesville, Florida, United States, 32608
2
GSK Investigational Site
Orlando, Florida, United States, 32809
3
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
4
GSK Investigational Site
Adelaide, South Australia, Australia, 5000