Healthy Subjects Clinical Trial
Official title:
Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
NCT number | NCT00487968 |
Other study ID # | TRA110087 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | June 15, 2007 |
Last updated | March 15, 2012 |
Start date | May 2007 |
Verified date | February 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2. | at initial dosing, 3hours, and 6 hours on Day 1 & 2. | ||
Secondary | Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits | all visits | ||
Secondary | - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 | done at Day 1 & 2 |
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