Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
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
1 other identifier
interventional
29
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2006
2 active sites
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
September 28, 2006
CompletedFirst Submitted
Initial submission to the registry
March 1, 2007
CompletedFirst Posted
Study publicly available on registry
March 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2008
CompletedNovember 13, 2017
November 1, 2017
1.3 years
March 1, 2007
November 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma levels and protein binding of eltrombopag
plasma levels/protein binding for eltrombopag
at Day 1 to Day 6.
Secondary Outcomes (3)
Safety will be assessed by: -eye exam
at Screening, Day -1, & followup
adverse assessment
Day 1 to followup
clinical labs, vital signs, & 12-lead electrocardiograms done
all days but Day 4
Study Arms (1)
Eltrombopag
EXPERIMENTALEltrombopag 50 mg oral (single dose)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Gainesville, Florida, 32608, United States
GSK Investigational Site
Saint Paul, Minnesota, 55114-1067, United States
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
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2007
First Posted
March 5, 2007
Study Start
September 28, 2006
Primary Completion
January 3, 2008
Study Completion
January 3, 2008
Last Updated
November 13, 2017
Record last verified: 2017-11