Last updated: 11/04/2018 12:56:38
Study Of SB-497115 in Healthy Subjects and Subjects with Mild, Moderate or Severe Renal 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 50 mg Eltrombopag in Healthy Subjects and in Subjects with Mild, Moderate, or Severe Renal Impairment
Trial description: The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney 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:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Plasma levels and protein binding of eltrombopag
Timeframe: at Day 1 to Day 6.
Secondary outcomes:
Safety will be assessed by: -eye exam
Timeframe: at Screening, Day -1, & followup
adverse assessment
Timeframe: Day 1 to followup
clinical labs, vital signs, & 12-lead electrocardiograms done
Timeframe: all days but Day 4
Interventions:
Drug: eltrombopag
Enrollment:
29
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)
September 2006 to January 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
Yes
- Healthy or have renal 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 kidney function
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy or have renal 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
- Negative drug, alcohol, and HIV tests.
Exclusion criteria:
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing kidney function
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females who are pregnant or nursing
- Have active hepatitis B or C
Trial location(s)
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55114-1067
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
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
2008-03-01
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 TRA104412 can be found on the GSK Clinical Study Register.
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