Eltrombopag Taste Testing in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487968
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Purpura, Thrombocytopenic, Idiopathic Drug: eltrombopag Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487968

United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00487968     History of Changes
Other Study ID Numbers: TRA110087
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:
healthy adult volunteers

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases