Eltrombopag Taste Testing in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00487968
First received: June 15, 2007
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy Subjects
Purpura, Thrombocytopenic, Idiopathic
Drug: eltrombopag
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits [ Time Frame: all visits ]
  • - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 [ Time Frame: done at Day 1 & 2 ]

Enrollment: 12
Study Start Date: May 2007
Intervention Details:
    Drug: eltrombopag
    Other Name: eltrombopag
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487968

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00487968     History of Changes
Other Study ID Numbers: TRA110087
Study First Received: June 15, 2007
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy adult volunteers
eltrombopag

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

ClinicalTrials.gov processed this record on April 23, 2014