NCT00359463

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2006

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2007

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

July 28, 2006

Last Update Submit

November 8, 2017

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Keywords

hepatitis C-associated thrombocytopeniachemotherapy induced thrombocytopeniathrombocytopeniahepatic impairmentchronic immune thrombocytopenia purpura

Outcome Measures

Primary Outcomes (1)

  • Plasma levels and protein binding of eltrombopag

    Day 1 to Day 6

Secondary Outcomes (1)

  • Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams

    throughout the study

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

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

Drug: eltrombopag

Subjects with hepatic impairment

EXPERIMENTAL

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

Drug: eltrombopag

Interventions

eltrombopagDRUG

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

Healthy subjectsSubjects with hepatic impairment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Gainesville, Florida, 32608, United States

Location

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Christchurch, 8011, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 20663991BACKGROUND

Related Links

MeSH Terms

Conditions

PurpuraThrombocytopenia

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsBlood Platelet DisordersCytopenia

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 2, 2006

Study Start

April 18, 2006

Primary Completion

March 7, 2007

Study Completion

March 7, 2007

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

NZ(1)US(2)AU(2)