Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-03 @ 7:44 AM
Study NCT ID:
NCT00674856
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C111751', 'term': 'naproxen-n-butyl nitrate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.', 'timeFrame': '8 days'}, {'measure': 'To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.', 'timeFrame': '8 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function', 'detailedDescription': 'This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.\n* Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health\n\nExclusion Criteria:\n\n* Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.\n* A history of alcohol or drug abuse.\n* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months\n* Clinically relevant abnormal ECG\n* Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).\n* Participation within 30 days prior to screening in another investigational study.'}, 'identificationModule': {'nctId': 'NCT00674856', 'acronym': 'HCT3012-X-106', 'briefTitle': 'A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'NicOx'}, 'officialTitle': 'A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects', 'orgStudyIdInfo': {'id': 'HCT 3012-X-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'naproxcinod', 'description': 'naproxcinod 750mg(375mg caps x2), administered twice a day.', 'interventionNames': ['Drug: naproxcinod']}], 'interventions': [{'name': 'naproxcinod', 'type': 'DRUG', 'description': '750mg', 'armGroupLabels': ['naproxcinod']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NicOx', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'NicOx', 'oldOrganization': 'NicOx.'}}}}