NCT00487968

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
Last Updated

March 19, 2012

Status Verified

February 1, 2011

First QC Date

June 15, 2007

Last Update Submit

March 15, 2012

Conditions

Healthy SubjectsPurpura, Thrombocytopenic, Idiopathic

Keywords

healthy adult volunteerseltrombopag

Outcome Measures

Primary Outcomes (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 Outcomes (2)

  • Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits

    all visits

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

    done at Day 1 & 2

Interventions

eltrombopagDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 19, 2007

Study Start

May 1, 2007

Last Updated

March 19, 2012

Record last verified: 2011-02

Locations

US(1)