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

November 8, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • GSK Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114-1067
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eltrombopag
Eltrombopag 50 mg oral (single dose)
Drug: eltrombopag
eltrombopag 50 mg oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be assessed by: -eye exam
Time Frame: at Screening, Day -1, & followup
eye exam safety findings
at Screening, Day -1, & followup
adverse assessment
Time Frame: Day 1 to followup
Adverse event review
Day 1 to followup
clinical labs, vital signs, & 12-lead electrocardiograms done
Time Frame: all days but Day 4
Clinical labs, vital signs and 12 lead electrocardiograms
all days but Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2006

Primary Completion (Actual)

January 3, 2008

Study Completion (Actual)

January 3, 2008

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (Estimate)

March 5, 2007

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRA104412

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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