CompletedPhase 1

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

United States29 participantsStarted 2006-09-28

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Plasma levels and protein binding of eltrombopag

Timeframe: at Day 1 to Day 6.

Trial details

NCT IDNCT00442871

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01-03

View on ClinicalTrials.gov More Purpura, Thrombocytopaenic, Idiopathic trials