Back to resultsEltrombopag Taste Testing in Healthy Adult Volunteers
Primary Purpose
Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects focused on measuring healthy adult volunteers, eltrombopag
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Secondary Outcome Measures
Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits
- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487968
Brief Title
Eltrombopag Taste Testing in Healthy Adult Volunteers
Official Title
Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
Keywords
healthy adult volunteers, eltrombopag
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
eltrombopag
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits
Time Frame
all visits
Title
- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
Time Frame
done at Day 1 & 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
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Eltrombopag Taste Testing in Healthy Adult Volunteers
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