Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01468558
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004087', 'term': 'Dihydroergotamine'}, {'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D004879', 'term': 'Ergotamines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkellerman@mappharma.com', 'phone': '650-386-3100', 'title': 'VP, Scientific Affairs', 'organization': 'MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All 24 subjects who received MAP0004 alone, 24 subjects who received MAP0004 with ketoconazole, and 22 subjects who received IV DHE are included in the adverse event analysis. Adverse events are presented by treatment arm, not necessarily by individual treatment (intervention) received.', 'eventGroups': [{'id': 'EG000', 'title': 'MAP0004 1.0mg', 'description': 'MAP0004 1.0mg via inhalation on Day 1 of Visit 2.', 'otherNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MAP0004 1.0mg + Ketoconazole', 'description': 'Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.', 'otherNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'IV DHE 1.0mg', 'description': 'IV DHE 1.0mg on Day 1 of Visit 3.', 'otherNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MAP0004 1.0mg', 'description': 'MAP0004 1.0mg via inhalation on Day 1 of Visit 2.'}, {'id': 'OG001', 'title': 'MAP0004 1.0mg + Ketoconazole', 'description': 'Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.'}, {'id': 'OG002', 'title': 'IV DHE 1.0mg', 'description': 'IV DHE 1.0mg on Day 1 of Visit 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2582.507', 'spread': '1137.829', 'groupId': 'OG000'}, {'value': '2495.100', 'spread': '1130.850', 'groupId': 'OG001'}, {'value': '27771.234', 'spread': '36191.528', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '48 hours', 'description': 'The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with available data at specified time points are included in the analysis population.'}, {'type': 'PRIMARY', 'title': 'AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MAP0004 1.0mg', 'description': 'MAP0004 1.0mg via inhalation on Day 1 of Visit 2.'}, {'id': 'OG001', 'title': 'MAP0004 1.0mg + Ketoconazole', 'description': 'Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.'}, {'id': 'OG002', 'title': 'IV DHE 1.0mg', 'description': 'IV DHE 1.0mg on Day 1 of Visit 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '3484.725', 'spread': '1221.423', 'groupId': 'OG000'}, {'value': '4070.611', 'spread': '1628.973', 'groupId': 'OG001'}, {'value': '9229.171', 'spread': '3130.093', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '48 hours', 'description': 'The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg\\*h/ml).', 'unitOfMeasure': 'pg*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with available data at specified time points are included in the analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'All subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg Intravenous (IV) Dihydroergotamine Mesylate (DHE).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'All subjects that were enrolled in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.58', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2011-10-28', 'resultsFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-19', 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration', 'timeFrame': '48 hours', 'description': 'The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).'}, {'measure': 'AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration', 'timeFrame': '48 hours', 'description': 'The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg\\*h/ml).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Drug Interaction Study in Normal Healthy Volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22174351', 'type': 'DERIVED', 'citation': 'Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'Compare the DHE pharmacokinetic profiles observed following administration of:\n\n1. MAP0004 (oral inhalation DHE)\n2. MAP0004 co-administered with oral Ketoconazole\n3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)\n\nCompare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Able to provide written Informed Consent\n* Male or Female subjects 18 to 45 years old\n* Female subjects who are practicing adequate contraception or who are sterile\n* Stable cardiac status\n* Normal rhythm or arrhythmia deemed clinically insignificant on ECG\n\nExclusion Criteria:\n\n* Contraindication to dihydroergotamine mesylate (DHE)\n* Use of any excluded concomitant medications within the 10 days prior to Visit 1\n* History of hemiplegic or basilar migraine\n* Participation in another investigational trial during the 12 weeks prior to Visit 1 or during this trial'}, 'identificationModule': {'nctId': 'NCT01468558', 'briefTitle': 'Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)', 'orgStudyIdInfo': {'id': 'MAP0004-CL-P104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).', 'interventionNames': ['Drug: MAP0004', 'Drug: IV DHE', 'Drug: Ketoconazole']}], 'interventions': [{'name': 'MAP0004', 'type': 'DRUG', 'description': 'MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2', 'armGroupLabels': ['All subjects']}, {'name': 'IV DHE', 'type': 'DRUG', 'otherNames': ['D.H.E.45®'], 'description': 'IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3', 'armGroupLabels': ['All subjects']}, {'name': 'Ketoconazole', 'type': 'DRUG', 'otherNames': ['Nizoral®'], 'description': 'Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Merthyr Tydfil', 'state': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Simbec Research Limited', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}