Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT05956002
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': True, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Any untoward findings identified on physical examination during the active collection period were captured as adverse events, if those findings met the definition of an AE.'}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 10, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'MedDRA v26.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Puncture site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 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{'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1620', 'spread': '26', 'groupId': 'OG000'}, {'value': '1529', 'spread': '19', 'groupId': 'OG001'}, {'value': '1538', 'spread': '19', 'groupId': 'OG002'}, {'value': '1391', 'spread': '22', 'groupId': 'OG003'}, {'value': '1510', 'spread': '22', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.66', 'ciLowerLimit': '91.33', 'ciUpperLimit': '98.12', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.96', 'ciLowerLimit': '91.69', 'ciUpperLimit': '98.34', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '85.86', 'ciLowerLimit': '82.90', 'ciUpperLimit': '88.92', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.24', 'ciLowerLimit': '89.76', 'ciUpperLimit': '96.84', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period', 'description': 'AUClast was calculated using linear/log trapezoidal method.', 'unitOfMeasure': 'Nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1694', 'spread': '26', 'groupId': 'OG000'}, {'value': '1594', 'spread': '20', 'groupId': 'OG001'}, {'value': '1605', 'spread': '19', 'groupId': 'OG002'}, {'value': '1447', 'spread': '23', 'groupId': 'OG003'}, {'value': '1580', 'spread': '22', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.36', 'ciLowerLimit': '90.97', 'ciUpperLimit': '97.89', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.75', 'ciLowerLimit': '91.41', 'ciUpperLimit': '98.20', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '85.44', 'ciLowerLimit': '82.43', 'ciUpperLimit': '88.55', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.28', 'ciLowerLimit': '89.61', 'ciUpperLimit': '97.10', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period', 'description': 'AUCinf was calculated as AUClast + (Clast\\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) for Etrasimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.18', 'spread': '22', 'groupId': 'OG000'}, {'value': '40.44', 'spread': '19', 'groupId': 'OG001'}, {'value': '40.03', 'spread': '18', 'groupId': 'OG002'}, {'value': '37.67', 'spread': '18', 'groupId': 'OG003'}, {'value': '39.98', 'spread': '21', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.70', 'ciLowerLimit': '90.38', 'ciUpperLimit': '99.22', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.72', 'ciLowerLimit': '88.59', 'ciUpperLimit': '97.04', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.24', 'ciLowerLimit': '83.35', 'ciUpperLimit': '91.31', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.59', 'ciLowerLimit': '88.24', 'ciUpperLimit': '97.17', 'estimateComment': 'The ratio and 90% CIs are expressed as percentages.', 'groupDescription': 'Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 hour', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '3.85', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '7.12', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '3.75', 'groupId': 'OG003'}, {'value': '-5.1', 'spread': '4.32', 'groupId': 'OG004'}]}]}, {'title': 'At 2 hours', 'categories': [{'measurements': [{'value': '-10.4', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '6.55', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '4.51', 'groupId': 'OG003'}, {'value': '-10.5', 'spread': '4.62', 'groupId': 'OG004'}]}]}, {'title': 'At 3 hours', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '-12.1', 'spread': '7.41', 'groupId': 'OG002'}, {'value': '-10.1', 'spread': '5.07', 'groupId': 'OG003'}, {'value': '-10.3', 'spread': '4.39', 'groupId': 'OG004'}]}]}, {'title': 'At 4 hours', 'categories': [{'measurements': [{'value': '-9.9', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '7.08', 'groupId': 'OG002'}, {'value': '-8.7', 'spread': '4.32', 'groupId': 'OG003'}, {'value': '-11.0', 'spread': '3.85', 'groupId': 'OG004'}]}]}, {'title': 'At 5 hours', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '6.98', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '4.27', 'groupId': 'OG003'}, {'value': '-4.4', 'spread': '4.46', 'groupId': 'OG004'}]}]}, {'title': 'At 6 hours', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.96', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '6.33', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '3.61', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '3.88', 'groupId': 'OG004'}]}]}, {'title': 'At 8 hours', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '4.75', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '3.63', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '6.48', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '6.10', 'groupId': 'OG003'}, {'value': '-3.8', 'spread': '7.99', 'groupId': 'OG004'}]}]}, {'title': 'At 24 hours', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '6.19', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '7.38', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '4.62', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '5.80', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1', 'description': 'Heart rate was measured in beats per minute.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose, met one or more of the criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect. AEs included SAEs and all non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 45', 'description': 'Clinical laboratory abnormalities test criteria included haematology: lymphocytes (10\\^3/ mm\\^3) and lymphocytes/leukocytes percentage (%) less than (\\<) 0.8\\* lower limit of normal (LLN), neutrophils, eosinophils, monocytes (10\\^3/mm\\^3), eosinophils/leukocytes monocytes/leukocytes (%) more than (\\>) 1.2\\* upper limit of normal (ULN); clinical chemistry: bicarbonate milliequivalents per liter (mEq/L) \\> 1.1\\* ULN; Urinalysis: urine hemoglobin, nitrite, leukocyte esterase greater than or equal to (\\>=) 1 and squamous epithelial cells /low power field (/LPF) \\> 4. Number of participants meeting any clinical laboratory abnormalities criteria is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Categorization of Vital Signs Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'Supine Systolic Blood Pressure (mmHg) Value <90', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Diastolic Blood Pressure (mmHg) Value <50', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Pulse Rate (beats/min) Value <40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Supine Pulse Rate (beats/min) Value >120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 45', 'description': 'Supine blood pressure (SBP) and pulse rate (PR) were measured. Vital sign criteria included: Systolic BP: \\<90 millimeter of mercury \\[mmHg\\]; Systolic BP change from baseline: maximum increase and decrease \\>=30 mmHg; Diastolic BP \\< 50 mmHg; Diastolic BP change from baseline: maximum decrease and increase \\>=20 mmHg; pulse rate \\<40 and \\>120 beats per minute.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg IR Tablet', 'description': 'Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG004', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'QTcF interval aggregate (Msec): 450 < Value <= 480', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF interval aggregate (Msec): 480 < Value <= 500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF interval aggregate (Msec): Value > 500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF interval aggregate (Msec): 30 <= Change <= 60', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QTcF interval aggregate (Msec): Change > 60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 45', 'description': "Standard 12-lead ECGs were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: QTcF interval, aggregate (milliseconds \\[msec\\]) 450 \\< Value \\<= 480, 480 \\< value \\<= 500, value \\> 500; 30 \\<= Change \\<= 60; Change \\> 60. Participants with any ECG abnormality criteria were reported in this outcome measure.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Assessment of Mouth Feel Based on Palatability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.21', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '17.14', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '10.03', 'groupId': 'OG003'}]}]}, {'title': 'At 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '5.36', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '15.84', 'groupId': 'OG002'}, {'value': '8.4', 'spread': '12.46', 'groupId': 'OG003'}]}]}, {'title': 'At 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '7.12', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '18.04', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '9.16', 'groupId': 'OG003'}]}]}, {'title': 'At 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '14.59', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '5.23', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '16.22', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '6.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to answer mouth feel (such as grittiness, stickiness, waxiness) of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse mouth feel.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) \\[Test\\]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Assessment of Bitterness Based on Palatability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '17.26', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.69', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '17.02', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '15.09', 'groupId': 'OG003'}]}]}, {'title': 'At 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.92', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '16.07', 'groupId': 'OG002'}, {'value': '7.9', 'spread': '12.39', 'groupId': 'OG003'}]}]}, {'title': 'At 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '6.53', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '18.52', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '11.49', 'groupId': 'OG003'}]}]}, {'title': 'At 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.65', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '17.50', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '5.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell about the degree of bitterness of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse bitterness.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) \\[Test\\]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3.48', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '4.04', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '5.26', 'groupId': 'OG003'}]}]}, {'title': 'At 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '3.34', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '4.26', 'groupId': 'OG003'}]}]}, {'title': 'At 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '3.36', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '4.10', 'groupId': 'OG003'}]}]}, {'title': 'At 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '4.44', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '10.16', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '2.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell about the degree of palatability attribute of tongue/mouth burns of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more tongue/mouth burns.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) \\[Test\\]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Assessment of Likeness of Throat Burn Based on Palatability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '13.48', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.77', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '4.35', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '7.04', 'groupId': 'OG003'}]}]}, {'title': 'At 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '12.16', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '3.46', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '12.03', 'groupId': 'OG003'}]}]}, {'title': 'At 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '12.12', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '7.04', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '18.69', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '17.98', 'groupId': 'OG003'}]}]}, {'title': 'At 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '12.32', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.95', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '25.19', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '17.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell the palatability attribute of throat burn of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more throat burn.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) \\[Test\\]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Assessment of Overall Liking Based on Palatability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 2 mg Mini Tablets in Applesauce', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg Mini Tablets in Chocolate Pudding', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG002', 'title': 'Etrasimod 2 mg Mini Tablets in Water', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition.'}, {'id': 'OG003', 'title': 'Etrasimod 2 mg Mini Tablets in Yogurt', 'description': 'Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition.'}], 'classes': [{'title': 'At 1 minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '4.90', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '16.69', 'groupId': 'OG002'}, {'value': '10.4', 'spread': '14.24', 'groupId': 'OG003'}]}]}, {'title': 'At 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '12.20', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '3.76', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '16.55', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '16.62', 'groupId': 'OG003'}]}]}, {'title': 'At 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '12.25', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '4.78', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '19.10', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '18.64', 'groupId': 'OG003'}]}]}, {'title': 'At 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '17.70', 'groupId': 'OG002'}, {'value': '9.8', 'spread': '16.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell the palatability attribute of overall liking of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated less overall liking.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) \\[Test\\]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence: A Then B Then C Then D Then E', 'description': 'Participants were randomized to receive a single oral dose of etrasimod 2 milligram (mg) clinical immediate release (IR) tablet with 240 milliliter (ml) of water on Day 1 of Period 1 under fasted conditions as reference (Treatment A) followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose.'}, {'id': 'FG001', 'title': 'Treatment Sequence: B Then D Then A Then C Then E', 'description': 'Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5ml water (Treatment D) as test 3 on Day 1 of Period 4 followed by single oral dose of etrasimod 2 mg clinical IR tablet (Treatment A) as reference with 240 ml of water on Day 1 Period 1 under fasted conditions, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose.'}, {'id': 'FG002', 'title': 'Treatment Sequence: C Then A Then D Then B Then E', 'description': 'Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3. Followed by single oral dose of etrasimod 2 mg clinical IR tablet (Treatment A) as reference with 240 ml of water on Day 1 of Period 1 under fasted conditions, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4 , Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose.'}, {'id': 'FG003', 'title': 'Treatment Sequence: D Then C Then B Then A Then E', 'description': 'Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2, followed by single oral dose of etrasimod 2 mg clinical IR tablet with 240 ml of water on Day 1 of Period 1 of each period under fasted conditions (Treatment A) as reference. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'comment': '1 participant who temporarily discontinued from study intervention resumed treatment', 'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 16 participants were enrolled in this study.', 'preAssignmentDetails': 'All participants received at least one dose of etrasimod prepared in different vehicles.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who were randomized to receive any of the treatment sequence in any of the period were included.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '11.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set (SAS) included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-01', 'size': 1310306, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-22T15:27', 'hasProtocol': True}, {'date': '2023-05-25', 'size': 297429, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-22T15:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2023-06-29', 'resultsFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period', 'description': 'AUClast was calculated using linear/log trapezoidal method.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period', 'description': 'AUCinf was calculated as AUClast + (Clast\\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) for Etrasimod', 'timeFrame': 'At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1', 'description': 'Heart rate was measured in beats per minute.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose, met one or more of the criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect. AEs included SAEs and all non-SAEs.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Up to Day 45', 'description': 'Clinical laboratory abnormalities test criteria included haematology: lymphocytes (10\\^3/ mm\\^3) and lymphocytes/leukocytes percentage (%) less than (\\<) 0.8\\* lower limit of normal (LLN), neutrophils, eosinophils, monocytes (10\\^3/mm\\^3), eosinophils/leukocytes monocytes/leukocytes (%) more than (\\>) 1.2\\* upper limit of normal (ULN); clinical chemistry: bicarbonate milliequivalents per liter (mEq/L) \\> 1.1\\* ULN; Urinalysis: urine hemoglobin, nitrite, leukocyte esterase greater than or equal to (\\>=) 1 and squamous epithelial cells /low power field (/LPF) \\> 4. Number of participants meeting any clinical laboratory abnormalities criteria is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Categorization of Vital Signs Results', 'timeFrame': 'Up to Day 45', 'description': 'Supine blood pressure (SBP) and pulse rate (PR) were measured. Vital sign criteria included: Systolic BP: \\<90 millimeter of mercury \\[mmHg\\]; Systolic BP change from baseline: maximum increase and decrease \\>=30 mmHg; Diastolic BP \\< 50 mmHg; Diastolic BP change from baseline: maximum decrease and increase \\>=20 mmHg; pulse rate \\<40 and \\>120 beats per minute.'}, {'measure': 'Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings', 'timeFrame': 'Up to Day 45', 'description': "Standard 12-lead ECGs were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: QTcF interval, aggregate (milliseconds \\[msec\\]) 450 \\< Value \\<= 480, 480 \\< value \\<= 500, value \\> 500; 30 \\<= Change \\<= 60; Change \\> 60. Participants with any ECG abnormality criteria were reported in this outcome measure."}, {'measure': 'Assessment of Mouth Feel Based on Palatability Questionnaire', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to answer mouth feel (such as grittiness, stickiness, waxiness) of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse mouth feel.'}, {'measure': 'Assessment of Bitterness Based on Palatability Questionnaire', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell about the degree of bitterness of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse bitterness.'}, {'measure': 'Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell about the degree of palatability attribute of tongue/mouth burns of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more tongue/mouth burns.'}, {'measure': 'Assessment of Likeness of Throat Burn Based on Palatability Questionnaire', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell the palatability attribute of throat burn of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more throat burn.'}, {'measure': 'Assessment of Overall Liking Based on Palatability Questionnaire', 'timeFrame': 'At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period', 'description': 'Participants were required to tell the palatability attribute of overall liking of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated less overall liking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bioavailability', 'etrasimod', 'adult'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5041034', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare how healthy adults process Etrasimod when taken in different forms. One form is Etrasimod taken without food. The other form is Etrasimod mixed with water and 3 different foods. The types of food used are applesauce, chocolate pudding or yogurt.\n\nThe study is seeking participants who are:\n\n* Aged 18 or older\n* Male or female who are healthy as determined by medical assessment\n* Body-mass index (BMI) of 16 to 32, and a total body weight \\> 50kg.\n\nThe study will take up to 2.5 months, including the screening period. Participants will have to stay at the study clinic for at least 45 days. This includes 5 study periods in total.\n\nParticipants will take Etrasimod as a tablet by mouth without food. Participants will also take Etrasimod sprinkled in soft food or water. Blood samples will be taken both before and after participants take Etrasimod. Participants will also answer questions for taste assessment purposes. A follow-up phone call will be made 20 to 27 days after the last study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* BMI 16 to 32 kg/m2\n* body weight more than 50kg\n\nExclusion Criteria:\n\n* Ongoing or past history of significant medical conditions\n* Eye disorders such as macular edema or uveitis\n* Ongoing or recent infections\n* Use of prescription or non prescription medications within 7 days of first dose\n* Smoking or using nicotine products equivalent to more than 5 cigarettes per day\n* History of severe allergic or anaphylactic reactions'}, 'identificationModule': {'nctId': 'NCT05956002', 'briefTitle': 'A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF ETRASIMOD (PF-07915503) MINI TABLETS IN WATER AND 3 FOOD VEHICLES COMPARED TO THE ETRASIMOD (PF-07915503) CLINICAL IR TABLETS UNDER FASTED CONDITIONS, AND TO EVALUATE MINI TABLET PALATABILITY IN HEALTHY ADULT PARTICIPANTS', 'orgStudyIdInfo': {'id': 'C5041034'}, 'secondaryIdInfos': [{'id': '2023-504411-32-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)', 'interventionNames': ['Drug: Estraimod Immediate Release (IR)', 'Drug: Etrasimod Mini Tab in water', 'Drug: Etrasimod Mini Tab in chocolate pudding', 'Drug: Etrasimod Mini Tab in yogurt', 'Drug: Etrasimod Mini Tab in applesauce']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)', 'interventionNames': ['Drug: Estraimod Immediate Release (IR)', 'Drug: Etrasimod Mini Tab in water', 'Drug: Etrasimod Mini Tab in chocolate pudding', 'Drug: Etrasimod Mini Tab in yogurt', 'Drug: Etrasimod Mini Tab in applesauce']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)', 'interventionNames': ['Drug: Estraimod Immediate Release (IR)', 'Drug: Etrasimod Mini Tab in water', 'Drug: Etrasimod Mini Tab in chocolate pudding', 'Drug: Etrasimod Mini Tab in yogurt', 'Drug: Etrasimod Mini Tab in applesauce']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)', 'interventionNames': ['Drug: Estraimod Immediate Release (IR)', 'Drug: Etrasimod Mini Tab in water', 'Drug: Etrasimod Mini Tab in chocolate pudding', 'Drug: Etrasimod Mini Tab in yogurt', 'Drug: Etrasimod Mini Tab in applesauce']}], 'interventions': [{'name': 'Estraimod Immediate Release (IR)', 'type': 'DRUG', 'description': 'an immediate release tablet', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Etrasimod Mini Tab in water', 'type': 'DRUG', 'description': 'very small tablet mixed in water', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Etrasimod Mini Tab in chocolate pudding', 'type': 'DRUG', 'description': 'very small tablet mixed in chocolate pudding', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Etrasimod Mini Tab in yogurt', 'type': 'DRUG', 'description': 'Very small tablet mixed in yogurt', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Etrasimod Mini Tab in applesauce', 'type': 'DRUG', 'description': 'Very small tablet mixed in applesauce', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'state': 'Bruxelles-capitale, Région de', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit - Brussels', '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'}}}}