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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00359463




Registration number
NCT00359463
Ethics application status
Date submitted
28/07/2006
Date registered
2/08/2006
Date last updated
13/11/2017

Titles & IDs
Public title
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
Scientific title
An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers With Mild, Moderate or Severe Hepatic Impairment
Secondary ID [1] 0 0
TRA103452
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Purpura, Thrombocytopaenic, Idiopathic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - eltrombopag

Active comparator: Healthy subjects - Subjects will receive a single 50 mg oral dose of eltrombopag.

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


Treatment: Drugs: eltrombopag
Subjects will be administered a single oral dose of 50 mg eltrombopag.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma levels and protein binding of eltrombopag
Timepoint [1] 0 0
Day 1 to Day 6
Secondary outcome [1] 0 0
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
Timepoint [1] 0 0
throughout the study

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/03/2007
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00359463