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

NCT ID: NCT00442871

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-28

Study Completion Date

2008-01-03

Brief Summary

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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.

Detailed Description

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Conditions

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Purpura, Thrombocytopaenic, Idiopathic

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eltrombopag

Eltrombopag 50 mg oral (single dose)

Group Type EXPERIMENTAL

eltrombopag

Intervention Type DRUG

eltrombopag 50 mg oral

Interventions

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eltrombopag

eltrombopag 50 mg oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Gainesville, Florida, United States

Site Status

GSK Investigational Site

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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Bauman JW, Vincent CT, Peng B, Wire MB, Williams DD, Park JW. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol. 2011 May;51(5):739-50. doi: 10.1177/0091270010372106. Epub 2010 Jul 27.

Reference Type BACKGROUND
PMID: 20663991 (View on PubMed)

Other Identifiers

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TRA104412

Identifier Type: -

Identifier Source: org_study_id