Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-30 @ 7:52 AM
Study NCT ID:
NCT01125904
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2010-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077547', 'term': 'Crizotinib'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-21', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A complete description of the sensory attributes of drug product prototype formulations (eg, aroma, flavor, texture, and mouthfeel).', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Crizotinib'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081018&StudyName=A%20Study%20To%20Investigate%20The%20Taste%20Of%20Crizotinib%20Liquid%20In%20Trained%20Healthy%20Adult%20Volunteers%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.", 'detailedDescription': 'Taste assessment of new formulation. Subjects will not ingest the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.\n* Subjects must be trained sensory panelists.\n* An informed consent document signed and dated by the subject or a legally acceptable representative.\n* Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.\n* A history of hypersensitivity to any inactive ingredients employed in the formulation(s).\n* Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.\n* Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.\n* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol."}, 'identificationModule': {'nctId': 'NCT01125904', 'briefTitle': 'A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of Crizotinib Oral Liquid', 'orgStudyIdInfo': {'id': 'A8081018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'crizotinib', 'interventionNames': ['Drug: crizotinib']}], 'interventions': [{'name': 'crizotinib', 'type': 'DRUG', 'description': 'Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.', 'armGroupLabels': ['crizotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}