Healthy SubjectsPhase 1NCT00487968
Eltrombopag Taste Testing in Healthy Adult Volunteers
A Phase 1 study testing eltrombopag in people with Healthy Subjects and Purpura, Thrombocytopenic, Idiopathic, run by GlaxoSmithKline at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- eltrombopag
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
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.
- Being tested
- eltrombopag
- Keywords
- healthy adult volunteers, eltrombopag
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Measured: 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
Measured: all visits
- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
Measured: done at Day 1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487968
- Sponsor's protocol ID
- TRA110087
- Status last verified
- Feb 2011
- First submitted
- 15 Jun 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00487968
- Acronym / sponsor ID
- TRA110087
- Keywords
- healthy adult volunteers, eltrombopag
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2007
- First posted
- 19 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eltrombopag | Drug | – |
Primary outcome
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.
2 secondary outcomes
Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits
Time frame: all visits
- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
Time frame: done at Day 1 & 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eltrombopag in people with Healthy Subjects and Purpura, Thrombocytopenic, Idiopathic, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.