Back to resultsStudy Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
Primary Purpose
Purpura, Thrombocytopaenic, Idiopathic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopaenic, Idiopathic focused on measuring Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eltrombopag
Arm Description
Eltrombopag 50 mg oral (single dose)
Outcomes
Primary Outcome Measures
Plasma levels and protein binding of eltrombopag
plasma levels/protein binding for eltrombopag
Secondary Outcome Measures
Safety will be assessed by: -eye exam
eye exam safety findings
adverse assessment
Adverse event review
clinical labs, vital signs, & 12-lead electrocardiograms done
Clinical labs, vital signs and 12 lead electrocardiograms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00442871
Brief Title
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 28, 2006 (Actual)
Primary Completion Date
January 3, 2008 (Actual)
Study Completion Date
January 3, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopaenic, Idiopathic
Keywords
Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eltrombopag
Arm Type
Experimental
Arm Description
Eltrombopag 50 mg oral (single dose)
Intervention Type
Drug
Intervention Name(s)
eltrombopag
Intervention Description
eltrombopag 50 mg oral
Primary Outcome Measure Information:
Title
Plasma levels and protein binding of eltrombopag
Description
plasma levels/protein binding for eltrombopag
Time Frame
at Day 1 to Day 6.
Secondary Outcome Measure Information:
Title
Safety will be assessed by: -eye exam
Description
eye exam safety findings
Time Frame
at Screening, Day -1, & followup
Title
adverse assessment
Description
Adverse event review
Time Frame
Day 1 to followup
Title
clinical labs, vital signs, & 12-lead electrocardiograms done
Description
Clinical labs, vital signs and 12 lead electrocardiograms
Time Frame
all days but Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
GSK Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114-1067
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20663991
Citation
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.
Results Reference
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Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
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