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Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment

NCT ID: NCT00359463

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-18

Study Completion Date

2007-03-07

Brief Summary

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The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver 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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hepatitis C-associated thrombocytopenia chemotherapy induced thrombocytopenia thrombocytopenia hepatic impairment chronic immune thrombocytopenia purpura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy subjects

Subjects will receive a single 50 mg oral dose of eltrombopag.

Group Type ACTIVE_COMPARATOR

eltrombopag

Intervention Type DRUG

Subjects will be administered a single oral dose of 50 mg eltrombopag.

Subjects with hepatic impairment

Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.

Group Type EXPERIMENTAL

eltrombopag

Intervention Type DRUG

Subjects will be administered a single oral dose of 50 mg eltrombopag.

Interventions

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eltrombopag

Subjects will be administered a single oral dose of 50 mg eltrombopag.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy or have liver 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.
* Body mass index (BMI-within acceptable range)
* Negative drug, alcohol, and HIV tests

Exclusion Criteria

* Taking a medication or therapy not approved by the study doctor
* Rapidly changing liver function
* Kidneys not working well
* Drug or alcohol abuse within past 6 months
* Used an investigational drug in the past 30 days
* Females that are pregnant or nursing
* Have active hepatitis B or C
* History of blood disorders
* History of various heart conditions (as noted by study doctor)
* Blood clotting problems or blood abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Orlando, Florida, United States

Site Status

GSK Investigational Site

Randwick, Sydney, New South Wales, Australia

Site Status

GSK Investigational Site

Adelaide, South Australia, Australia

Site Status

GSK Investigational Site

Christchurch, , New Zealand

Site Status

Countries

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United States Australia New Zealand

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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TRA103452

Identifier Type: -

Identifier Source: org_study_id