Eltrombopag Taste Testing in Healthy Adult Volunteers

Healthy Subjects Clinical Trial

Official title:

Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487968
• Other study ID #: TRA110087
• 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
• 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

• Healthy Subjects
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

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