Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-04-04 @ 6:01 PM
Study NCT ID:
NCT00863161
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2009-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Impairment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545087', 'term': 'lesogaberan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic blood samples', 'timeFrame': '15 samples during 0-72 hours'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic urine samples', 'timeFrame': '8 samples during 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'tolerability', 'exposure', 'healthy', 'renally impaired subjects'], 'conditions': ['Reflux', 'Renal Excretion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed informed consent\n* Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment\n\nExclusion Criteria:\n\n* History of heart disease\n* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder'}, 'identificationModule': {'nctId': 'NCT00863161', 'briefTitle': 'Renal Impairment Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355', 'orgStudyIdInfo': {'id': 'D9120C00022'}, 'secondaryIdInfos': [{'id': 'EudraCTnr 2008-007471-25'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD3355 65 + 65 mg capsule', 'interventionNames': ['Drug: AZD3355']}], 'interventions': [{'name': 'AZD3355', 'type': 'DRUG', 'otherNames': ['Lesogaberan'], 'description': 'capsule, oral, single dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Luleå', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Wolfgang Kuhn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}