Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
Conditions
Keywords
healthy adult volunteers, eltrombopag
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.
Interventions
DRUGeltrombopag
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits | all visits |
| - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 | done at Day 1 & 2 |
Countries
United States
Outcome results
None listed