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

An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal Impairment

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00442871

Enrollment

Registered

2007-03-05

Start date

2006-09-28

Completion date

2008-01-03

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Keywords

Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia

Brief 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.

Interventions

DRUGeltrombopag

eltrombopag 50 mg oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma levels and protein binding of eltrombopag	at Day 1 to Day 6.	plasma levels/protein binding for eltrombopag

Secondary

Measure	Time frame	Description
Safety will be assessed by: -eye exam	at Screening, Day -1, & followup	eye exam safety findings
adverse assessment	Day 1 to followup	Adverse event review
clinical labs, vital signs, & 12-lead electrocardiograms done	all days but Day 4	Clinical labs, vital signs and 12 lead electrocardiograms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026