Viewing Study NCT02576951

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Ignite Creation Date: 2025-12-24 @ 11:57 PM
Ignite Modification Date: 2026-01-11 @ 4:36 AM
Study NCT ID: NCT02576951
Status: COMPLETED
Last Update Posted: 2019-02-26
First Post: 2015-10-14
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Galcanezumab in Healthy Participants
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628360', 'term': 'galcanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 20 Weeks', 'description': 'All randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Galcanezumab 240 mg - Part A', 'description': 'Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo - Part A', 'description': 'Participants received placebo by subcutaneous injection.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Galcanezumab 300 mg Lyophilized - Part B', 'description': 'Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 25, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Galcanezumab 300 mg Solution - Part B', 'description': 'Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 20, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dental discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vessel puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Biopsy breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Physical breast examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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[{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Laryngeal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 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by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.93', 'groupId': 'OG000', 'lowerLimit': '20.93', 'upperLimit': '84.03'}, {'value': '41.95', 'groupId': 'OG001', 'lowerLimit': '13.92', 'upperLimit': '83.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)', 'denoms': [{'units': 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'day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable plasma AUC zero to tlast CGRP data in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Galcanezumab Solution - Part B', 'description': 'Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.'}, {'id': 'OG001', 'title': '300 mg Galcanezumab Lyophilized - Part B', 'description': 'Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '36', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '240 mg Galcanezumab Solution - Part A', 'description': 'Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection.'}, {'id': 'FG001', 'title': 'Placebo - Part A', 'description': 'Participants received placebo by subcutaneous injection.'}, {'id': 'FG002', 'title': '300 mg Galcanezumab Lyophilized - Part B', 'description': 'Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.'}, {'id': 'FG003', 'title': '300 mg Galcanezumab Solution - Part B', 'description': 'Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '178', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '240 mg Galcanezumab Solution - Part A', 'description': 'Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.'}, {'id': 'BG001', 'title': 'Placebo - Part A', 'description': 'Participants received placebo by subcutaneous injection.'}, {'id': 'BG002', 'title': '300 mg Galcanezumab Lyophilized - Part B', 'description': 'Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.'}, {'id': 'BG003', 'title': '300 mg Galcanezumab Solution - Part B', 'description': 'Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '11.4', 'groupId': 'BG002'}, {'value': '40.6', 'spread': '12.8', 'groupId': 'BG003'}, {'value': '40.5', 'spread': '12.44', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '178', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Basal Metabolic Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.27', 'spread': '3.86', 'groupId': 'BG000'}, {'value': '30.67', 'spread': '4.32', 'groupId': 'BG001'}, {'value': '27.57', 'spread': '4.14', 'groupId': 'BG002'}, {'value': '27.55', 'spread': '3.97', 'groupId': 'BG003'}, {'value': '27.56', 'spread': '4.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2015-10-14', 'resultsFirstSubmitDate': '2018-10-19', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-19', 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of Participants With an Injection Site Adverse Event', 'timeFrame': 'Part A: Predose through 48 hours post dose', 'description': 'If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.'}, {'measure': 'Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab', 'timeFrame': 'Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.'}, {'measure': 'Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab', 'timeFrame': 'Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.'}], 'secondaryOutcomes': [{'measure': 'Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)', 'timeFrame': 'Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).'}, {'measure': 'Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)', 'timeFrame': 'Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC \\[0 to Tlast\\]) of Plasma Calcitonin Gene Related Peptide (CGRP).'}, {'measure': 'Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP', 'timeFrame': 'Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.'}, {'measure': 'Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)', 'timeFrame': 'Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).'}, {'measure': 'Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)', 'timeFrame': 'Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC\\[0-tlast\\]) of Plasma Calcitonin Gene Related Peptide (CGRP).'}, {'measure': 'Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP', 'timeFrame': 'Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose', 'description': 'Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31482569', 'type': 'DERIVED', 'citation': 'Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n* To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)\n* To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous \\[SC\\]) (Part B).\n\nInformation about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female healthy participants\n* Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive\n\nExclusion Criteria:\n\n\\- Currently smoke in excess of 5 cigarettes/day'}, 'identificationModule': {'nctId': 'NCT02576951', 'briefTitle': 'A Study of Galcanezumab in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation', 'orgStudyIdInfo': {'id': '16084'}, 'secondaryIdInfos': [{'id': 'I5Q-MC-CGAO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Galcanezumab Solution Formulation-Part A', 'description': 'Galcanezumab solution formulation in a prefilled syringe given SC once.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-Part A', 'description': 'Placebo in a prefilled syringe given SC once.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Galcanezumab Lyophilized Formulation-Part B', 'description': 'Galcanezumab lyophilized (freeze dried) formulation given SC once.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Galcanezumab Solution Formulation-Part B', 'description': 'Galcanezumab solution formulation in a prefilled syringe given SC once.', 'interventionNames': ['Drug: Galcanezumab']}], 'interventions': [{'name': 'Galcanezumab', 'type': 'DRUG', 'otherNames': ['LY2951742'], 'description': 'Administered SC', 'armGroupLabels': ['Galcanezumab Lyophilized Formulation-Part B', 'Galcanezumab Solution Formulation-Part A', 'Galcanezumab Solution Formulation-Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo-Part A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}}}}