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

Purpura, Thrombocytopaenic, Idiopathic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442871
• Other study ID #: TRA104412
• Status: Completed
• Phase: Phase 1
• First received: March 1, 2007
• Last updated: November 8, 2017
• Start date: September 28, 2006
• Est. completion date: January 3, 2008

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 3, 2008
• Est. primary completion date: January 3, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopaenic, Idiopathic
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Renal Insufficiency

Intervention

Drug:
• eltrombopag
eltrombopag 50 mg oral

Locations

Country	Name	City	State
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels and protein binding of eltrombopag	plasma levels/protein binding for eltrombopag	at Day 1 to Day 6.
Secondary	Safety will be assessed by: -eye exam	eye exam safety findings	at Screening, Day -1, & followup
Secondary	adverse assessment	Adverse event review	Day 1 to followup
Secondary	clinical labs, vital signs, & 12-lead electrocardiograms done	Clinical labs, vital signs and 12 lead electrocardiograms	all days but Day 4

External Links

•   Results for study TRA104412 can be found on the GSK Clinical Study Register.