Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT01284595
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2011-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C548875', 'term': 'AZD 8931'}]}}, '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': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects', 'timeFrame': 'Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose'}, {'measure': 'To investigate the pharmacokinetic variable of AZD8931 in plasma', 'timeFrame': 'Multiple PK blood samples from pre-dose until 240 hours post last dose'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety and tolerability of AZD8931 given orally', 'timeFrame': 'Frequent safety measurements during the study from screening period to follow-up'}, {'measure': 'To investigate the AZD8931 metabolites variables in plasma', 'timeFrame': 'Multiple PK blood samples from pre-dose until 240 hours post last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radioactive carbon', 'Absorption', 'Distribution', 'Metabolism', 'Excretion', 'Healthy Volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25007130', 'type': 'DERIVED', 'citation': 'Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1626&filename=D0102C00007_Clinical_Study_Protocol_redacted_for_posting.pdf', 'label': 'Clinical\\_Study\\_Protocol\\_redacted'}]}, 'descriptionModule': {'briefSummary': 'Study to Assess the Absorption, Metabolism and Excretion of \\[14C\\]AZD8931 after a Single-Dose Oral Administration'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.\n* Regular daily bowel movements (ie, production of at least 1 stool per day).\n* Non-smokers or ex-smokers who have stopped smoking for \\>3 months before Visit 1 and have not used nicotine products for \\>3 months\n* Healthy Male volunteers aged 50 to 65 years, inclusive\n\nExclusion Criteria:\n\n* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \\>5 mSv in the last year, \\>10 mSv in the last 5 years, or a cumulative total of \\>1 mSv per year of life\n* Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).\n* History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)'}, 'identificationModule': {'nctId': 'NCT01284595', 'briefTitle': 'Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '[14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'D0102C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD8931', 'description': '\\[14C\\] AZD8931', 'interventionNames': ['Drug: [14C] AZD8931']}], 'interventions': [{'name': '[14C] AZD8931', 'type': 'DRUG', 'description': 'Single 160 mg oral dose administered on Day 1', 'armGroupLabels': ['AZD8931']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Darren Wilbraham, MBBS, DCPSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital"}, {'name': 'Mary Stuart', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}