Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-28 @ 3:04 PM
Study NCT ID:
NCT00777361
Status:
TERMINATED
Last Update Posted:
2010-11-18
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C490152', 'term': 'ispronicline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2008-10-21', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio.', 'timeFrame': 'Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours.'}, {'measure': 'Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss)', 'timeFrame': '19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks).'}], 'secondaryOutcomes': [{'measure': 'identity of major metabolites in plasma and excreta', 'timeFrame': '4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks).'}, {'measure': 'Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis.', 'timeFrame': 'From enrollment to follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mass balance', 'AZD3480, Pharmacokinetics, Healthy volunteers'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically healthy volunteers\n* Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)\n\nExclusion Criteria:\n\n* History of clinically significant diseases or illness.\n* Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.'}, 'identificationModule': {'nctId': 'NCT00777361', 'acronym': 'MB', 'briefTitle': 'Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers With Different CYP2D6 Genotype', 'orgStudyIdInfo': {'id': 'D3690C00017'}, 'secondaryIdInfos': [{'id': 'EudraCT No.: 2007-005903-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD3480 iv', 'description': 'Single iv infusion AZD3480', 'interventionNames': ['Drug: AZD3480']}, {'type': 'EXPERIMENTAL', 'label': 'Oral [14C] AZD3480', 'description': 'Single oral dose \\[14C\\]AZD3480', 'interventionNames': ['Drug: AZD3480']}], 'interventions': [{'name': 'AZD3480', 'type': 'DRUG', 'description': 'Iv single dose, 4-hour infusion of 25 mg', 'armGroupLabels': ['AZD3480 iv']}, {'name': 'AZD3480', 'type': 'DRUG', 'description': 'Oral solution single dose of 50 mg', 'armGroupLabels': ['Oral [14C] AZD3480']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Macclesfield', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Research site', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}], 'overallOfficials': [{'name': 'Björn Paulsson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Södertälje, Sweden'}, {'name': 'Tim Mant, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles Drug Research Unit @ Guy´s Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Björn Paulsson, MD, PhD, Medical Science Director Clinical Neuroscience TA', 'oldOrganization': 'AstraZeneca R&D Södertälje'}}}}