Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-18 @ 5:33 PM
Study NCT ID:
NCT00487968
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2007-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eltrombopag Taste Testing in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520809', 'term': 'eltrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2007-06-15', 'studyFirstSubmitQcDate': '2007-06-15', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.'}], 'secondaryOutcomes': [{'measure': 'Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits', 'timeFrame': 'all visits'}, {'measure': '- physical exam and an echocardiogram (ECG) will be done at Day 1 & 2', 'timeFrame': 'done at Day 1 & 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy adult volunteers', 'eltrombopag'], 'conditions': ['Healthy Subjects', 'Purpura, Thrombocytopenic, Idiopathic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adult based on a medical evaluation by a responsible physician\n* male or female adult between 18 and 55 years old\n* female subjects who are not pregnant or lactating\n* females who are unable to have children must have documented medical verification\n* females who are able to have children must have a negative pregnancy test\n* capable of giving written informed consent\n\nExclusion criteria:\n\n* subjects who are unable to taste bitterness or are extrememly sensitive to bitterness\n* participated in a clinical trial within 30 days\n* exposure to more than four new medicines within 12 months prior to the first day of dosing\n* history of sensitivity to any of the study medications'}, 'identificationModule': {'nctId': 'NCT00487968', 'briefTitle': 'Eltrombopag Taste Testing in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'TRA110087'}}, 'armsInterventionsModule': {'interventions': [{'name': 'eltrombopag', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}