Eltrombopag Taste Testing in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects Purpura, Thrombocytopenic, Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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eltrombopag

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes