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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00487968
Other study ID # TRA110087
Secondary ID
Status Completed
Phase Phase 1
First received June 15, 2007
Last updated March 15, 2012
Start date May 2007

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
eltrombopag


Locations

Country Name City State
United States GSK Investigational Site Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2. at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Secondary Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits all visits
Secondary - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 done at Day 1 & 2
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