Eltrombopag Taste Testing in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

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