Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-19 @ 8:04 AM
Study NCT ID:
NCT02209766
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2014-08-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'H.Negi@astrazeneca.com', 'phone': '+81 6 4803 3533', 'title': 'Hideo Negi', 'phoneExt': '4716', 'organization': 'CO RIA TA, R&D'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.', 'eventGroups': [{'id': 'EG000', 'title': '2 g D4884 Japanese', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4 g D4884 Japanese', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '4 g D4884 Caucasian', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0.166'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '82.22', 'spread': '45.10', 'groupId': 'OG000'}, {'value': '220.0', 'spread': '17.70', 'groupId': 'OG001'}, {'value': '158.1', 'spread': '34.98', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax in Plasma Baseline-adjusted Total EPA, Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.50', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '32.04', 'spread': '69.51', 'groupId': 'OG000'}, {'value': '90.10', 'spread': '21.50', 'groupId': 'OG001'}, {'value': '63.63', 'spread': '46.12', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax in Plasma Baseline-adjusted Total DHA, Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '157.4', 'spread': '32.73', 'groupId': 'OG000'}, {'value': '314.8', 'spread': '26.09', 'groupId': 'OG001'}, {'value': '238.8', 'spread': '33.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '5.50', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '7.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '58.47', 'spread': '49.15', 'groupId': 'OG000'}, {'value': '88.21', 'spread': '89.54', 'groupId': 'OG001'}, {'value': '101.1', 'spread': '34.06', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '6.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG003', 'title': 'Placebo Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to discontinued', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first dosing (Day1) until follow-up (Day25)', 'description': 'Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '531.2', 'spread': '75.81', 'groupId': 'OG000'}, {'value': '621.9', 'spread': '278.9', 'groupId': 'OG001'}, {'value': '1044', 'spread': '48.00', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '2072', 'spread': '39.29', 'groupId': 'OG000'}, {'value': '4067', 'spread': '43.52', 'groupId': 'OG001'}, {'value': '3136', 'spread': '28.93', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '138.2', 'spread': '80.07', 'groupId': 'OG000'}, {'value': '432.9', 'spread': '39.97', 'groupId': 'OG001'}, {'value': '783.2', 'spread': '78.67', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG001', 'title': '4g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'OG002', 'title': '4g D5885 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '1108', 'spread': '38.37', 'groupId': 'OG000'}, {'value': '2213', 'spread': '31.67', 'groupId': 'OG001'}, {'value': '2105', 'spread': '25.70', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'FG001', 'title': '2 g D5884 Japanese Placebo', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'FG002', 'title': '4 g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'FG003', 'title': '4g D5844 Japanese Placebo', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'FG004', 'title': '4g D5884 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '86 male subjects were screened.', 'preAssignmentDetails': 'Of the 86 subjects, 43 did not meet the inclusion/exclusion criteria, 14 decided not to participate in the study and 5 had other reasons for declining participation in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '2 g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'BG001', 'title': '4 g D5884 Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'BG002', 'title': '4 g D5884 Caucasian', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'BG003', 'title': 'Placebo Japanese', 'description': 'Single dose followed by once daily for 14 consecutive days'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '6.15', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '5.25', 'groupId': 'BG002'}, {'value': '32.3', 'spread': '6.12', 'groupId': 'BG003'}, {'value': '30.3', 'spread': '6.93', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '60.42', 'spread': '8.109', 'groupId': 'BG000'}, {'value': '69.08', 'spread': '7.059', 'groupId': 'BG001'}, {'value': '72.92', 'spread': '10.169', 'groupId': 'BG002'}, {'value': '62.63', 'spread': '6.371', 'groupId': 'BG003'}, {'value': '66.26', 'spread': '9.078', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '20.67', 'spread': '0.852', 'groupId': 'BG000'}, {'value': '22.67', 'spread': '1.517', 'groupId': 'BG001'}, {'value': '22.55', 'spread': '1.724', 'groupId': 'BG002'}, {'value': '21.40', 'spread': '1.370', 'groupId': 'BG003'}, {'value': '21.82', 'spread': '1.559', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2014-08-01', 'resultsFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)', 'timeFrame': 'from first dosing (Day1) until follow-up (Day25)', 'description': 'Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)'}], 'secondaryOutcomes': [{'measure': 'Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Tmax in Plasma Baseline-adjusted Total EPA, Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Tmax in Plasma Baseline-adjusted Total DHA, Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}, {'measure': 'AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose', 'timeFrame': 'Day1-3, 4, 7, 11, 14, 17-18 and 25'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Pharmacokinetics', 'Pharmacodynamics', 'D5884', 'Japanese', 'Caucasian'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.', 'detailedDescription': 'This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a single and multiple dose open-label study.\n\nTwo dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2 cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.\n\nFollowing a screening period of a maximum of 42 days, subjects will reside at the study facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose administration in all 3 study arms will be done in the following sequence: a single dose of D5884 or placebo will be administered; this will be followed by a 2-day washout period; after the washout period, multiple doses of D5884 or placebo will be administered, once daily for 14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd cohort (Study Arm C) will receive 4 g D5884 (n=6).\n\nThe PK analysis included all evaluable PK data appropriate for the evaluation of interest (eg, with no major protocol deviations or violations thought to significantly affect the PK of the drug) from all subjects who received D5884.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adult male, 20 to 45 years of age (inclusive)\n2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2 for Caucasian subjects. BMI calculations to be conducted on height and weight values obtained at Visit 1\n3. Medically healthy with clinically insignificant screening results (eg, laboratory profile, medical history, ECGs, physical examination). Haemoglobin has to be ≥ the lower limit of the study site reference range, 12-lead ECG must have QT interval corrected for heart rate using Fridericia's formula(QTcF) \\>340 msec and \\<450 msec\n4. No habitual use of drug(s) and non-tobacco/nicotine-containing products for a minimum of 6 months prior to dosing\n5. Subjects must be willing and able to give written informed consent by signing an Institutional Review Board(IRB)-approved informed consent form (ICF) prior to admission to this study and follow the restrictions and procedures outlined for the study.\n6. Mean fasting Triglyceride(TG) at -4 and -2 weeks of \\<150 mg/dL, and %TG change of \\<30% between Weeks -4 and -2\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product(IP) during the 4 months prior to enrolment\n2. Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI\n3. An individual who has abnormal laboratory values (ie, suggesting hepatic, renal, cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate current or past medical history for participation based on the decision of the principal investigator(PI)\n4. A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease\n5. A positive urine drug/alcohol test at screening or admission (Visit 3, Day -1). (The drug test includes testing for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates and tricyclic anti-depressants. The alcohol test is an alcohol breath assessment.)\n6. A positive test for syphilis, human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus antibodies.\n7. Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months of the planned time of admission\n8. Current evidence, or a history of alcoholism or drug abuse within the 2 years prior to admission\n9. A known sensitivity or allergy to soybeans, fish and/or shellfish\n10. A hypersensitivity or idiosyncratic reaction to compounds related to EPA and/or DHA\n11. Had used any prescription medication within 14 days prior to admission\n12. Had used any over-the-counter (OTC) medication, including herbal products (bromelains, danshen, dong quai \\[Angelica sinensis\\], garlic, ginko biloba, ginseng, and St. John's wort), within the 7 days prior to admission\n13. Had used any drugs known to significantly inhibit \\[strong or moderate\\] or induce liver enzymes involved in drug metabolism \\[cytochrome P450\\]) within 30 days prior to admission\n14. Had donated blood or had had significant blood loss in excess of 200 mL within 1 month prior to admission or in excess of 400 mL within 3 months prior to admission\n15. Had donated plasma within 7 days prior to admission\n16. History of drug abuse or past history of alcohol abuse or habit of taking nicotine-containing product(s) on a daily basis\n17. Those who have difficulty in giving blood during blood sampling via the peripheral vein\n18. Any potential subjects who are considered as not eligible for the study in the opinion of the PI and/or the sub-investigator"}, 'identificationModule': {'nctId': 'NCT02209766', 'briefTitle': 'A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884', 'orgStudyIdInfo': {'id': 'D5881C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D5884', 'description': 'D5884 capsule, Per oral(po)', 'interventionNames': ['Drug: D5884']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule, po', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D5884', 'type': 'DRUG', 'description': '1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian', 'armGroupLabels': ['D5884']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1. st cohort: Dose 1(2g) D5884(n=3) in Japanese\n2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8900081', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'CPC Clinical Trial Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}], 'overallOfficials': [{'name': 'Hiroyuki Fukase, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPC Clinical Trial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}