Eltrombopag Taste Testing in Healthy Adult Volunteers

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Purpura, Thrombocytopenic, Idiopathic

Healthy Subjects

Treatments

Drug: eltrombopag

Study type

Interventional

Funder types

Industry

Identifiers

NCT00487968

TRA110087

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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