Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-03-03 @ 8:15 AM
Study NCT ID:
NCT02125292
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2014-04-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Taste Assessment Study of SHP429 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 days', 'eventGroups': [{'id': 'EG000', 'title': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.', 'otherNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mesalamine (Applesauce)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.', 'otherNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG001', 'title': 'Mesalamine (Applesauce)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG002', 'title': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post-dose', 'description': 'A taste assessment was completed immediately after investigational product was administered to assess the subject\'s taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Detected an Aftertaste of Mesalamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG001', 'title': 'Mesalamine (Applesauce)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG002', 'title': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes post-dose', 'description': 'An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG001', 'title': 'Mesalamine (Applesauce)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG002', 'title': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes post-dose', 'description': 'An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject\'s rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG001', 'title': 'Mesalamine (Applesauce)', 'description': 'One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}, {'id': 'OG002', 'title': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post-dose', 'description': 'The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received all 3 treatments'}], 'classes': [{'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious Adverse Event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 days', 'description': 'Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Important Laboratory Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received all 3 treatments'}], 'classes': [{'title': 'Hematology', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Biochemistry', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': "Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory's normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Important Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received all 3 treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': "Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who received all 3 treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}, {'id': 'FG001', 'title': 'Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}, {'id': 'FG002', 'title': 'Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}, {'id': 'FG003', 'title': 'Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}, {'id': 'FG004', 'title': 'Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}, {'id': 'FG005', 'title': 'Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt', 'description': 'Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.'}], 'periods': [{'title': 'First Intervention (1 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (1 Hour)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '11.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Non-white, black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.59', 'spread': '13.312', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.2', 'spread': '9.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.348', 'spread': '3.4331', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2014-04-25', 'resultsFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-01', 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine', 'timeFrame': 'Immediately post-dose', 'description': 'A taste assessment was completed immediately after investigational product was administered to assess the subject\'s taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.'}, {'measure': 'Number of Participants Who Detected an Aftertaste of Mesalamine', 'timeFrame': '5 minutes post-dose', 'description': 'An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.'}, {'measure': 'Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine', 'timeFrame': '5 minutes post-dose', 'description': 'An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject\'s rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.'}, {'measure': 'Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis', 'timeFrame': 'Immediately post-dose', 'description': 'The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event', 'timeFrame': '4 days', 'description': 'Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.'}, {'measure': 'Number of Participants With Potentially Clinically Important Laboratory Results', 'timeFrame': '1 day', 'description': "Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory's normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant."}, {'measure': 'Number of Participants With Potentially Clinically Important Vital Signs', 'timeFrame': '1 day', 'description': "Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important."}, {'measure': 'Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results', 'timeFrame': '1 day', 'description': 'Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal, healthy, adult male and female volunteers, without evidence of active or chronic disease'}, 'identificationModule': {'nctId': 'NCT02125292', 'briefTitle': 'Taste Assessment Study of SHP429 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, 3-period Crossover Taste Assessment Study to Characterize the Palatability of SHP429 When the Contents Are Sprinkled Onto Soft Foods or Emptied Into a Cup and Administered With Water in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'SHP429-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine (Vanilla Yogurt)', 'description': 'One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'EXPERIMENTAL', 'label': 'Mesalamine (Applesauce)', 'description': 'One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'EXPERIMENTAL', 'label': 'Mesalamine (Dosing Cup)', 'description': 'One 500mg capsule contents emptied into a dosing cup and taken with water', 'interventionNames': ['Drug: Mesalamine']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'otherNames': ['Pentasa, SHP429'], 'armGroupLabels': ['Mesalamine (Applesauce)', 'Mesalamine (Dosing Cup)', 'Mesalamine (Vanilla Yogurt)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}