Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT01775904
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Two Dosage Forms of LY2886721 in Healthy Participants
Sponsor:
Organization:
Raw JSON
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'Application site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 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Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG001', 'title': 'LY2886721 ODT (no Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG002', 'title': 'LY2886721 ODT (Water, Fed)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG003', 'title': 'LY2886721 ODT (Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'spread': '46', 'groupId': 'OG000'}, {'value': '195', 'spread': '29', 'groupId': 'OG001'}, {'value': '181', 'spread': '18', 'groupId': 'OG002'}, {'value': '173', 'spread': '37', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 96 hours post-dose', 'unitOfMeasure': 'nanograms / milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug with evaluable LY2886721 Cmax data.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2886721 Capsule (Water, Fasting)', 'description': 'A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG001', 'title': 'LY2886721 ODT (no Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG002', 'title': 'LY2886721 ODT (Water, Fed)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG003', 'title': 'LY2886721 ODT (Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '24.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '6.00'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '12.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through 96 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug with evaluable LY2886721 tmax data.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2886721 Capsule (Water, Fasting)', 'description': 'A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG001', 'title': 'LY2886721 ODT (no Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG002', 'title': 'LY2886721 ODT (Water, Fed)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG003', 'title': 'LY2886721 ODT (Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2300', 'spread': '24', 'groupId': 'OG000'}, {'value': '2380', 'spread': '19', 'groupId': 'OG001'}, {'value': '2480', 'spread': '19', 'groupId': 'OG002'}, {'value': '2270', 'spread': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 96 hours post-dose', 'unitOfMeasure': 'nanograms * hour / milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-tlast) data.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2886721 Capsule (Water, Fasting)', 'description': 'A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG001', 'title': 'LY2886721 ODT (no Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG002', 'title': 'LY2886721 ODT (Water, Fed)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}, {'id': 'OG003', 'title': 'LY2886721 ODT (Water, Fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2320', 'spread': '24', 'groupId': 'OG000'}, {'value': '2390', 'spread': '19', 'groupId': 'OG001'}, {'value': '2490', 'spread': '19', 'groupId': 'OG002'}, {'value': '2290', 'spread': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 96 hours post-dose', 'unitOfMeasure': 'nanograms * hour / milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-∞) data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Study Population', 'description': 'All participants who entered the study and received at least 1 dose of study drug.'}], 'periods': [{'title': 'LY2886721 ODT (no Water, Fasting)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'First Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'LY2886721 Capsule (Water, Fasting)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Second Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'LY2886721 ODT (Water, Fed)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Third Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'LY2886721 ODT (Water, Fasting)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'comment': 'One participant was not dosed in this period due to an adverse event (AE).', 'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All participants who entered the study and received at least 1 dose of study drug.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '17.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2013-01-23', 'resultsFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-09', 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721', 'timeFrame': 'Baseline through 96 hours post-dose'}, {'measure': 'Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721', 'timeFrame': 'Baseline through 96 hours post-dose'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721', 'timeFrame': 'Baseline through 96 hours post-dose'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721', 'timeFrame': 'Baseline through 96 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.\n\nThis study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\\^2), inclusive, at screening\n* At least 4 participants who are greater than 55 years of age\n* Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product\n* Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone \\[FSH\\] level greater than 40 milli-international units per milliliter \\[mIU/mL\\])\n* Have venous access sufficient to allow for blood sampling as per the protocol\n\nExclusion Criteria:\n\n* Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have participated, within the last 30 days, in a clinical trial involving an investigational product\n* Have known allergies to LY2886721, related compounds, or any components of the formulation\n* Have an abnormality in the 12-lead electrocardiogram (ECG)\n* Have a significantly abnormal blood pressure as determined by the investigator\n* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data\n* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody\n* Have a history of, or current, significant ophthalmologic disease\n* Show evidence of significant active neuropsychiatric disease or history of suicide attempt'}, 'identificationModule': {'nctId': 'NCT01775904', 'briefTitle': 'A Study of Two Dosage Forms of LY2886721 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects', 'orgStudyIdInfo': {'id': '14249'}, 'secondaryIdInfos': [{'id': 'I4O-MC-BACG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2886721 Capsule (water, fasting)', 'description': 'Reference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods.', 'interventionNames': ['Drug: LY2886721 in a Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'LY2886721 ODT (no water, fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods.', 'interventionNames': ['Drug: LY2886721 in an orally disintegrating tablet (ODT)']}, {'type': 'EXPERIMENTAL', 'label': 'LY2886721 ODT (water, fed)', 'description': 'A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods.', 'interventionNames': ['Drug: LY2886721 in an orally disintegrating tablet (ODT)']}, {'type': 'EXPERIMENTAL', 'label': 'LY2886721 ODT (water, fasting)', 'description': 'A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods.', 'interventionNames': ['Drug: LY2886721 in an orally disintegrating tablet (ODT)']}], 'interventions': [{'name': 'LY2886721 in a Capsule', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY2886721 Capsule (water, fasting)']}, {'name': 'LY2886721 in an orally disintegrating tablet (ODT)', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY2886721 ODT (no water, fasting)', 'LY2886721 ODT (water, fasting)', 'LY2886721 ODT (water, fed)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}