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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Purpura, Thrombocytopaenic, Idiopathic

Treatments: Drug: eltrombopag

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442871

TRA104412

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Eltrombopag

Experimental group

Description:

Eltrombopag 50 mg oral (single dose)

Treatment:

Drug: eltrombopag