Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-06 @ 1:33 AM
Study NCT ID:
NCT01723618
Status:
COMPLETED
Last Update Posted:
2012-11-29
First Post:
2012-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2012-11-01', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics - maximum plasma concentration (Cmax)', 'timeFrame': 'Pre-dose and until 12 hours post-dose', 'description': 'Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured'}, {'measure': 'Pharmacokinetics - time to maximum plasma concentration (tmax)', 'timeFrame': 'Pre-dose til 12 hours post-dose', 'description': 'Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured.'}, {'measure': 'Pharmacokinetics - Area under the plasma concentration curve (AUC)', 'timeFrame': 'Pre-dose until 12 hours post-dose', 'description': 'Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured.'}, {'measure': 'Pharmacokinetics - elimination half life (t1/2)', 'timeFrame': 'pre-dose until 12 hours post-dose', 'description': 'Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured'}], 'secondaryOutcomes': [{'measure': 'Dose linearity', 'timeFrame': 'Pre-dose and until 12 hours post-dose', 'description': 'Evaluation of dose linearity in the dose range 10 - 40 mg'}, {'measure': 'Potential for accumulation', 'timeFrame': 'Pre-dose untill 12 hours post-dose', 'description': 'To estimate the accumulation of CRD007 in the dose range 10 - 40 mg'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurisms']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infra-renal abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial'}, 'identificationModule': {'nctId': 'NCT01723618', 'briefTitle': 'Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.', 'organization': {'class': 'INDUSTRY', 'fullName': 'RSPR Pharma AB'}, 'officialTitle': 'An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)', 'orgStudyIdInfo': {'id': 'Cardoz-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRD007 10 mg', 'description': 'CRD007, 10 mg tablet, single dose', 'interventionNames': ['Drug: CRD007']}, {'type': 'EXPERIMENTAL', 'label': 'CRD007 25 mg', 'description': 'CRD007, 25 mg tablet, single dose', 'interventionNames': ['Drug: CRD007']}, {'type': 'EXPERIMENTAL', 'label': 'CRD007 40 mg', 'description': 'CRD007, 40 mg tablet, single dose', 'interventionNames': ['Drug: CRD007']}], 'interventions': [{'name': 'CRD007', 'type': 'DRUG', 'armGroupLabels': ['CRD007 10 mg', 'CRD007 25 mg', 'CRD007 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8800', 'city': 'Viborg', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Department of Vascular Surgery Viborg Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Nikolaj F Groendal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RSPR Pharma AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}