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OpenTrials
Completed

NCT Number: NCT00442871

Study Of SB-497115 in Healthy Subjects and 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.

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Key information

Conditions

Purpura, Thrombocytopaenic, Idiopathic Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Renal Insufficiency Signs and Symptoms Skin Manifestations Thrombocytopenia Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eltrombopag

Drug

eltrombopag 50 mg oral

Primary outcomes

  1. Plasma levels and protein binding of eltrombopag

    Time frame: at Day 1 to Day 6.

    plasma levels/protein binding for eltrombopag

Secondary outcomes

  1. Safety will be assessed by: -eye exam

    Time frame: at Screening, Day -1, & followup

    eye exam safety findings

  2. adverse assessment

    Time frame: Day 1 to followup

    Adverse event review

  3. clinical labs, vital signs, & 12-lead electrocardiograms done

    Time frame: all days but Day 4

    Clinical labs, vital signs and 12 lead electrocardiograms

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2007
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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