Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 8:39 AM
Study NCT ID:
NCT01332903
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2011-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597960', 'term': 'N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood', 'timeFrame': 'From pre-dose until 168 hours post last dose', 'description': 'To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \\[14C\\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).'}, {'measure': 'To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax).', 'timeFrame': 'From pre-dose until 168hours post last dose'}, {'measure': 'To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance.', 'timeFrame': 'From pre-dose until 168hours post last dose'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety and tolerability of AZD5069 given orally', 'timeFrame': 'From screening visit, Day 12, up to follow up visit', 'description': 'Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29856004', 'type': 'DERIVED', 'citation': 'Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1340&filename=D3550C00013_Study_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \\[14C\\] AZD5069.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) of ≥18 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-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1\n* Healthy Male volunteers aged 50 and over\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 last 5 years\n* History of alcohol abuse or excessive intake of alcohol as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT01332903', 'briefTitle': 'Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D3550C00013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '\\[14C\\] AZD5069', 'interventionNames': ['Drug: [14C] AZD5069']}], 'interventions': [{'name': '[14C] AZD5069', 'type': 'DRUG', 'description': 'Single 120 mg oral dose administered on Day 1', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Prof. Tim Mant, FRCP, FFPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Quintiles Drug Research Unit at Guy's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}