Eltrombopag Taste Testing in Healthy Adult Volunteers
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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.
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 ]
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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