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Completed

NCT Number: NCT00487968

Eltrombopag Taste Testing in Healthy Adult Volunteers

Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.

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Key information

Conditions

Healthy Subjects Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adult based on a medical evaluation by a responsible physician
  • male or female adult between 18 and 55 years old
  • female subjects who are not pregnant or lactating
  • females who are unable to have children must have documented medical verification
  • females who are able to have children must have a negative pregnancy test
  • capable of giving written informed consent

Exclusion criteria

  • subjects who are unable to taste bitterness or are extrememly sensitive to bitterness
  • participated in a clinical trial within 30 days
  • exposure to more than four new medicines within 12 months prior to the first day of dosing
  • history of sensitivity to any of the study medications

Treatment and study plan

eltrombopag

Drug

Primary outcomes

  1. To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.

    Time frame: at initial dosing, 3hours, and 6 hours on Day 1 & 2.

Secondary outcomes

  1. Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits

    Time frame: all visits

  2. - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2

    Time frame: done at Day 1 & 2

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers

Important dates

Study start
2007
First posted
Jun 19, 2007
Registry last updated
Mar 19, 2012

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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