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

GlaxoSmithKline29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Interventions

eltrombopagDRUG

eltrombopag 50 mg oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Plasma levels and protein binding of eltrombopag

plasma levels/protein binding for eltrombopag

Time frame: at Day 1 to Day 6.

Secondary Outcomes

Safety will be assessed by: -eye exam

eye exam safety findings

Time frame: at Screening, Day -1, & followup

adverse assessment

Adverse event review

Time frame: Day 1 to followup

clinical labs, vital signs, & 12-lead electrocardiograms done

Clinical labs, vital signs and 12 lead electrocardiograms

Time frame: all days but Day 4

Data from ClinicalTrials.gov

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