Study Of SB-497115 in Healthy Subjects and Subjects With... | NCT00442871

Studies
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

NCT00442871

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 13, 2017Actual

Enrollment

29Actual

Phase

Phase 1

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Interventions

eltrombopag

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2006Actual

Primary Completion Date

Jan 3, 2008Actual

Completion Date

Jan 3, 2008Actual

First Submitted Date

Mar 1, 2007

First Submission Date that Met QC Criteria

Mar 1, 2007

First Posted Date

Mar 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2017

Last Update Posted Date

Nov 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eltrombopag	Experimental	Eltrombopag 50 mg oral (single dose)	Drug: eltrombopag

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eltrombopag	Drug	eltrombopag 50 mg oral	Eltrombopag

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma levels and protein binding of eltrombopag	plasma levels/protein binding for eltrombopag	at Day 1 to Day 6.

Secondary Outcomes

Measure	Description	Time Frame
Safety will be assessed by: -eye exam	eye exam safety findings	at Screening, Day -1, & followup
adverse assessment	Adverse event review

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Gainesville	Florida	32608	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20663991	Background	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.

ID	Term
D011693	Purpura
D051437	Renal Insufficiency
D013921	Thrombocytopenia

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006470	Hemorrhage