Eltrombopag Taste Testing in Healthy Adult Volunteers

GlaxoSmithKline12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy Subjects Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopagDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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