Eltrombopag Taste Testing in Healthy Adult Volunteers

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00487968
• Collaborator: (none)
• Enrollment: 12
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Purpura, Thrombocytopenic, Idiopathic	Drug: eltrombopag	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
• Study Start Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits [all visits]

2. - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 [done at Day 1 & 2]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00487968
• Other Study ID Numbers: TRA110087
• First Posted: Jun 19, 2007
• Last Update Posted: Mar 19, 2012
• Last Verified: Feb 1, 2011

• Keywords provided by GlaxoSmithKline: healthy adult volunteers; eltrombopag
• Additional relevant MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Mar 19, 2012