Last updated: 11/04/2018 12:57:51
Eltrombopag Taste Testing in Healthy Adult Volunteers
GSK study ID
TRA110087
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Timeframe: at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Secondary outcomes:
Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits
Timeframe: all visits
- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
Timeframe: done at Day 1 & 2
Interventions:
Enrollment:
12
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
May 2007 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- healthy adult based on a medical evaluation by a responsible physician
- male or female adult between 18 and 55 years old
- subjects who are unable to taste bitterness or are extrememly sensitive to bitterness
- participated in a clinical trial within 30 days
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
OVERLAND PARK, Kansas, United States, 66211
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-25-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website