Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT00832169
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574562', 'term': 'AZD1386'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386', 'timeFrame': 'Until >90% of predicted total radioactivity has been recovered'}, {'measure': 'Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta', 'timeFrame': 'Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h'}], 'secondaryOutcomes': [{'measure': 'AZD1386 metabolites in plasma+excreta if feasable', 'timeFrame': 'Predose, 1h, 4h, 8h 24h'}, {'measure': 'Safety + tolerability of AZD1386', 'timeFrame': 'Predose, 2h, 6h, 12h, 24h, 48h, 168h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.\n* Healthy volunteer must have regular bowel movements (at least once daily)\n\nExclusion Criteria:\n\n* History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.\n* A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.\n* Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.'}, 'identificationModule': {'nctId': 'NCT00832169', 'briefTitle': 'Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D5090C00015'}, 'secondaryIdInfos': [{'id': 'EudractCT: 2008-006552-22'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD1386']}], 'interventions': [{'name': 'AZD1386', 'type': 'DRUG', 'description': '1 dose of oral solution', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macclesfield', 'state': 'CHESHIRE', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}], 'overallOfficials': [{'name': 'Raj Chetty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca R&D, CPU Alderley Park, UK'}, {'name': 'Lars Ståhle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca R&D, Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience', 'oldOrganization': 'AstraZeneca R&D Södertälje, Sweden'}}}}