Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

Completed · Phase 1

Conditions studied: Purpura, Thrombocytopaenic, Idiopathic

In brief

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.

Key facts

Study ID

NCT00442871

Run by

GlaxoSmithKline

People needed

29

Starts

2006-09-28

Expected to finish

2008-01-03

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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