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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 website
https://clinicaltrials.gov/show/NCT00359463
Trial related presentations / publications
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.
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

Summary results
Other publications