Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-03 @ 10:40 PM
Study NCT ID:
NCT03916393
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PF-06651600 Taste Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects reporting overall liking of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.'}, {'measure': 'Percentage of subjects reporting overall liking of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Overall liking assesses the degree that a participant likes a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.'}, {'measure': 'Number of subjects reporting saltiness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Percentage of subjects reporting saltiness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Saltiness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Number of subjects reporting bitterness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Percentage of subjects reporting bitterness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Number of subjects reporting mouth feel of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Percentage of subjects reporting mouth feel of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Number of subjects reporting sourness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Percentage of subjects reporting sourness of drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Sourness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Number of subjects reporting tongue/mouth burn from drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Percentage of subjects reporting tongue/mouth burn from drug formulation', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire'}, {'measure': 'Number of subjects reporting formulation preference', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.'}, {'measure': 'Percentage of subjects reporting formulation preference', 'timeFrame': 'Baseline through 20 minutes post dose', 'description': 'Formulation preference assesses the degree that a participant prefers a drug formulation based on sensory attributes experienced by the participant after tasting a product. It is scored based on a measurement of taste questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PF-06651600', 'Palatability', 'Bitrex', 'Taste Study'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981021&StudyName=A+SINGLE+BLIND%2C+RANDOMIZED%2C+CROSS-OVER+STUDY+IN+HEALTHY+ADULT+PARTICIPANTS+TO+INVESTIGATE+THE+PALATABILITY+OF+ORAL+FORMULATIONS+OF+PF-06651600+FOR+PEDIATRIC+USE', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult participants. A group of approximately 10 participants will assess the sensory attributes (taste and palatability) of 4 different formulations of an investigational product (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a specified sequence in 1 day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lb)\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Infection with Hepatitis B, C or HIV\n* Participants with conditions that affect their ability to taste\n* Participants who currently smoke'}, 'identificationModule': {'nctId': 'NCT03916393', 'briefTitle': 'PF-06651600 Taste Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A SINGLE BLIND, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY ADULT PARTICIPANTS TO INVESTIGATE THE PALATABILITY OF ORAL FORMULATIONS OF PF-06651600 FOR PEDIATRIC USE', 'orgStudyIdInfo': {'id': 'B7981021'}, 'secondaryIdInfos': [{'id': '2019-000108-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06651600 Treatment A', 'description': 'Active pharmaceutical ingredient (API)solution in water', 'interventionNames': ['Drug: PF-06651600 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06651600 Treatment B', 'description': 'API in sweetened solution', 'interventionNames': ['Drug: PF-06651600 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06651600 Treatment C', 'description': 'API blend suspension in water', 'interventionNames': ['Drug: PF-06651600 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06651600 Treatment D', 'description': 'API blend suspension in apple sauce', 'interventionNames': ['Drug: PF-06651600 20 mg']}, {'type': 'OTHER', 'label': 'Bitrex (Registered) Treatment E', 'description': 'Positive control for bitterness', 'interventionNames': ['Other: Bitrex solution']}], 'interventions': [{'name': 'PF-06651600 20 mg', 'type': 'DRUG', 'description': 'PF-06651600 in four (4) different oral formulations will be administered in different periods.', 'armGroupLabels': ['PF-06651600 Treatment A', 'PF-06651600 Treatment B', 'PF-06651600 Treatment C', 'PF-06651600 Treatment D']}, {'name': 'Bitrex solution', 'type': 'OTHER', 'description': 'Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.', 'armGroupLabels': ['Bitrex (Registered) Treatment E']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'state': 'Be-bru', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}