Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-20 @ 10:46 AM
Study NCT ID:
NCT00572650
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic measures', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability measures', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type-2 diabetes, DPP-4 inhibitor, vildagliptin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 75 years of age (inclusive).\n* Male, non-fertile female or female of childbearing potential using a medically approved birth control method.\n* Body mass index (BMI) ≤42 kg/m2 (inclusive) at Screening.\n* Able to provide written informed consent prior to study participation.\n* Able to communicate well with the investigator and comply with the requirements of the study.\n\nFor renal insufficient patients only\n\n* Patients must have stable renal disease without evidence of renal progressive disease\n* If patient is diabetic, must be treated with standard anti-diabetic therapy andmust agree to continue their anti-diabetic therapy throughout the duration of the study.\n* If patient is diabetic, must be on a stable dose of standard anti-diabetic therapy or diet and exercise regimen over the past 4 weeks prior to Screening.\n\nFor healthy subjects only\n\n* No current significant medical conditions as determined by history and physical.\n* A serum creatinine with a calculated CrCl of \\>80 ml/min.\n* Matched to renal impaired patients (Group A) undergoing study by age (±5 years), sex and weight (±10% BMI).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:\n\n* Pregnant or lactating female.\n* A history of certain disorders as specified in the protocol.\n* Subjects that have been enrolled in a LAF237 (vildagliptin) study or other DPP-4 inhibitor studies six months prior to Baseline.\n* History of renal transplant at any time in the past and on immunosuppressant therapy.\n* Acute infections which may affect blood glucose control within 4 weeks prior to Screening and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.\n* Certain electrocardiogram (ECG) abnormalities:\n* Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.\n* Liver disease such as cirrhosis or positive hepatitis B and C.\n* Any alcohol related hepatic disease.\n* Patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis)\n* Concurrent medical condition that may interfere with the interpretation of safety and tolerability data during the study.\n* Use of certain medications as specified in the protocol.\n* Laboratory abnormalities as defined by the protocol\n* History of active substance abuse (including alcohol) within the past 2 years.\n* Smokers defined as any subject who reports heavy cigarette use (i.e., 10 or more cigarettes per day). Urine cotinine will also be measured and recorded at Screening and Baseline.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00572650', 'briefTitle': 'Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of LAF237 and Its Metabolites in Mild Renal Impaired Patients Compared to Age, Sex and Weight-matched Healthy Volunteers Following Daily Doses of 100 mg LAF237 for 14 Days', 'orgStudyIdInfo': {'id': 'CLAF237A2117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: vildagliptin']}], 'interventions': [{'name': 'vildagliptin', 'type': 'DRUG', 'description': '16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'NOVARTIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigator site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}