Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT00715702
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2008-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of AZD5672 in Renally Impaired Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553747', 'term': 'N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2008-07-11', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK variables', 'timeFrame': 'Frequent sampling occasions during study period'}], 'secondaryOutcomes': [{'measure': 'Safety variables (adverse events, blood pressure, pulse, safety lab)', 'timeFrame': 'During the treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AZD5672'], 'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed written informed consent.\n* Females should not be of childbearing potential\n* Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.\n\nExclusion Criteria:\n\n* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \\>20mg once daily, medications that prolong QT/QTc interval\n* Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)\n* Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)"}, 'identificationModule': {'nctId': 'NCT00715702', 'briefTitle': 'Safety Study of AZD5672 in Renally Impaired Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1710C00020'}, 'secondaryIdInfos': [{'id': 'EudraCt nr 2007-007541-'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients with Moderate renal impairment and matched volunteers', 'interventionNames': ['Drug: AZD5672']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data', 'interventionNames': ['Drug: AZD5672']}], 'interventions': [{'name': 'AZD5672', 'type': 'DRUG', 'description': '100 mg oral single dose', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Rod Hepburn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Charnwood, UK'}, {'name': 'Angelika Weil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APEX GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Layton, MD, PhD, Medical Science Director', 'oldOrganization': 'AstraZeneca R&D Alderely Park'}}}}