Last updated: 11/04/2018 12:55:56
Study Of Eltrombopag in Healthy Subjects and Volunteers with Mild, Moderate or Severe Hepatic Impairment
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Plasma levels and protein binding of eltrombopag
Timeframe: Day 1 to Day 6
Secondary outcomes:
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
Timeframe: throughout the study
Interventions:
Drug: eltrombopag
Enrollment:
33
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bauman J, Peng B, Williams D, Wook Park J. Effect of Hepatic or Renal Impairment on Eltrombopag Pharmacokinetics. [J Clin Pharmacol]. 2010; 0: 0091270010372106v1 .
Bauman JW, Vincent CT, Peng B, Williams DD, Wook Park J.Effect of Hepatic or Renal Impairment on Eltrombopag Pharmacokinetics.J Clin Pharmacol.2011;51(5):739-750
Medical condition
Purpura, Thrombocytopaenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
April 2006 to March 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing liver function
Inclusion and exclusion 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
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
Trial location(s)
Location
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Status
Recruiting
Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Recruiting
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-07-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 103452 can be found on the GSK Clinical Study Register.
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