Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-31 @ 11:43 PM
Study NCT ID:
NCT01154634
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2010-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'phone': '+44 1625 518062', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.', 'otherNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.', 'otherNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.', 'otherNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Disturbance In Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Euphoric Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Daydreaming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reflux Episodes 0 to 3 Hours Post Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '149'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '40'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 3 hours post meal', 'description': 'Total number of reflux episodes 0 to 3 hours post meal', 'unitOfMeasure': 'Episodes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.'}, {'type': 'SECONDARY', 'title': 'Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '51'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '26'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '16.8', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '33'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 3 hours post meal', 'description': 'Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.', 'unitOfMeasure': 'relaxations', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Curve(AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '251.5', 'groupId': 'OG000', 'lowerLimit': '188.4', 'upperLimit': '335.7'}, {'value': '906.6', 'groupId': 'OG001', 'lowerLimit': '732.7', 'upperLimit': '1122'}, {'value': '2825', 'groupId': 'OG002', 'lowerLimit': '2185', 'upperLimit': '3653'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.'}, {'type': 'SECONDARY', 'title': 'Average Plasma Concentration (C Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.46', 'groupId': 'OG000', 'lowerLimit': '35.04', 'upperLimit': '58.98'}, {'value': '175.8', 'groupId': 'OG001', 'lowerLimit': '142.4', 'upperLimit': '217.1'}, {'value': '506.8', 'groupId': 'OG002', 'lowerLimit': '405.0', 'upperLimit': '634.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 to 4 hours post dose', 'description': 'Average plasma concentration', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '103.8', 'groupId': 'OG000', 'lowerLimit': '76.09', 'upperLimit': '141.5'}, {'value': '378.0', 'groupId': 'OG001', 'lowerLimit': '315.0', 'upperLimit': '453.5'}, {'value': '911.7', 'groupId': 'OG002', 'lowerLimit': '767.3', 'upperLimit': '1083'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Maximum plasma concentration', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.750', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '4.000'}, {'value': '0.750', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '1.250'}, {'value': '1.000', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '4.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Time to maximum plasma concentration (Tmax)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (T Half)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.221', 'groupId': 'OG000', 'lowerLimit': '1.042', 'upperLimit': '1.430'}, {'value': '1.416', 'groupId': 'OG001', 'lowerLimit': '1.222', 'upperLimit': '1.640'}, {'value': '1.584', 'groupId': 'OG002', 'lowerLimit': '1.414', 'upperLimit': '1.774'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Terminal half-life (T half)', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.\n\nTwo samples were not analyzed for T half due to technical reasons.'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Change of Laboratory Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'OG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'OG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-entry to follow-up', 'description': 'Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First 5 mg, Then Placebo, Then 16 mg, Then 40 mg', 'description': 'period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.'}, {'id': 'FG001', 'title': 'First 40 mg, Then 16 mg, Then Placebo, Then 5 mg', 'description': 'period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.'}, {'id': 'FG002', 'title': 'First 16 mg, Then 5 mg, Then 40 mg, Then Placebo', 'description': 'period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.'}, {'id': 'FG003', 'title': 'First Placebo, Then 40 mg, Then 5 mg, Then 16 mg', 'description': 'period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg'}], 'periods': [{'title': 'Period 1 - First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2 - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3- Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4 - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 5 - Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 6 - Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 7 - Fourth Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In total 25 participants were enrolled into the study at 2 medical centres (14 and 11 participants), 20 of them were randomised to treatment (10 at each medical centre) and all these 20 participants completed the study.', 'preAssignmentDetails': "After enrolment, participant's eligibility for assignment to treatment was based on inclusion and exclusion criteria."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD2516 5 mg', 'description': 'Loading dose: 3 \\* AZD2516 1 mg capsules. Maintenance doses: 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules and 1 \\* AZD2516 1 mg capsule, 2 \\* placebo capsules.'}, {'id': 'BG001', 'title': 'AZD2516 16 mg', 'description': 'Loading dose: 2 \\* AZD2516 5mg capsule, 1 \\* placebo capsule. Maintenance dose: 3 \\* AZD2516 1 mg capsule and 3 \\* AZD2516 1 mg capsule.'}, {'id': 'BG002', 'title': 'AZD2516 40 mg', 'description': 'Loading dose: 2 \\* AZD2616 10 mg capsules, 1 \\* placebo capsule. Maintenance dose: 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule and 2 \\* AZD2616 5 mg capsules, 1 \\* placebo capsule.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Loading dose: 3 \\* placebo capsules. Maintenance dose: 3 \\* placebo capsules and 3 \\* placebo capsules.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'Age (years)', 'categories': [{'measurements': [{'value': '31', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '25', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '5.9', 'groupId': 'BG002'}, {'value': '23', 'spread': '4.2', 'groupId': 'BG003'}, {'value': '26.95', 'spread': '6.3', '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': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2010-06-15', 'resultsFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-05', 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reflux Episodes 0 to 3 Hours Post Meal', 'timeFrame': '0 to 3 hours post meal', 'description': 'Total number of reflux episodes 0 to 3 hours post meal'}], 'secondaryOutcomes': [{'measure': 'Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal', 'timeFrame': '0 to 3 hours post meal', 'description': 'Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.'}, {'measure': 'Area Under the Plasma Concentration Curve(AUC)', 'timeFrame': '0 to 12 hours post dose', 'description': 'Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method'}, {'measure': 'Average Plasma Concentration (C Average)', 'timeFrame': '1 to 4 hours post dose', 'description': 'Average plasma concentration'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': '0 to 12 hours post dose', 'description': 'Maximum plasma concentration'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': '0 to 12 hours post dose', 'description': 'Time to maximum plasma concentration (Tmax)'}, {'measure': 'Terminal Half-life (T Half)', 'timeFrame': '0 to 12 hours post dose', 'description': 'Terminal half-life (T half)'}, {'measure': 'Clinically Relevant Change of Laboratory Variables', 'timeFrame': 'Pre-entry to follow-up', 'description': 'Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacodynamic effect', 'Reflux inhibition'], 'conditions': ['Reflux']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.', 'detailedDescription': 'A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed informed consent\n* Healthy male subjects\n* Age 18-45 years, inclusive\n\nExclusion Criteria:\n\n* Clinically significant illness within the 2 weeks prior to the first dose of study drug\n* History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease\n* Need for concomitant medications during the study'}, 'identificationModule': {'nctId': 'NCT01154634', 'briefTitle': 'Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Two-centre, Phase IIa Pharmacodynamic Cross-over Study to Assess the Effect of AZD2516 on the Total Number of Reflux Episodes in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D3830C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First 5 mg, then placebo, then 16 mg, then 40 mg', 'description': 'period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.', 'interventionNames': ['Drug: AZD2516, 5 mg', 'Drug: AZD2516, 16 mg', 'Drug: AZD2516, 40 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'First 40 mg, then 16 mg, then placebo, then 5 mg', 'description': 'period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.', 'interventionNames': ['Drug: AZD2516, 5 mg', 'Drug: AZD2516, 16 mg', 'Drug: AZD2516, 40 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'First 16 mg, then 5 mg, then 40 mg, then placebo', 'description': 'period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.', 'interventionNames': ['Drug: AZD2516, 5 mg', 'Drug: AZD2516, 16 mg', 'Drug: AZD2516, 40 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'First placebo, then 40 mg, then 5 mg, then 16 mg', 'description': 'period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg', 'interventionNames': ['Drug: AZD2516, 5 mg', 'Drug: AZD2516, 16 mg', 'Drug: AZD2516, 40 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'AZD2516, 5 mg', 'type': 'DRUG', 'description': 'Capsule, oral', 'armGroupLabels': ['First 16 mg, then 5 mg, then 40 mg, then placebo', 'First 40 mg, then 16 mg, then placebo, then 5 mg', 'First 5 mg, then placebo, then 16 mg, then 40 mg', 'First placebo, then 40 mg, then 5 mg, then 16 mg']}, {'name': 'AZD2516, 16 mg', 'type': 'DRUG', 'description': 'Capsule, oral', 'armGroupLabels': ['First 16 mg, then 5 mg, then 40 mg, then placebo', 'First 40 mg, then 16 mg, then placebo, then 5 mg', 'First 5 mg, then placebo, then 16 mg, then 40 mg', 'First placebo, then 40 mg, then 5 mg, then 16 mg']}, {'name': 'AZD2516, 40 mg', 'type': 'DRUG', 'description': 'Capsule, oral', 'armGroupLabels': ['First 16 mg, then 5 mg, then 40 mg, then placebo', 'First 40 mg, then 16 mg, then placebo, then 5 mg', 'First 5 mg, then placebo, then 16 mg, then 40 mg', 'First placebo, then 40 mg, then 5 mg, then 16 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, oral', 'armGroupLabels': ['First 16 mg, then 5 mg, then 40 mg, then placebo', 'First 40 mg, then 16 mg, then placebo, then 5 mg', 'First 5 mg, then placebo, then 16 mg, then 40 mg', 'First placebo, then 40 mg, then 5 mg, then 16 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Mark Berner Hansen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Molndal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}