Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT01632358
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': '14 days after treatment', 'description': 'Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure'}, {'measure': 'Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)', 'timeFrame': 'Day 1 and Day 14 profile', 'description': 'The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)'}, {'measure': 'Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)', 'timeFrame': 'Day 1', 'description': 'The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)'}, {'measure': 'Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data', 'timeFrame': 'Day 14', 'description': 'The Racc ratio from the plasma concentration-time data'}, {'measure': 'Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data', 'timeFrame': 'Day 14', 'description': 'The AUCtau, from the plasma concentration-time data'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'tolerability', 'pharmacokinetics'], 'conditions': ['Dyslipidaemia']}, 'descriptionModule': {'briefSummary': 'The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients 18 to 80 years (inclusive) of age.\n* Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.\n* Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment\n* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes\n* Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.\n* Pregnant or nursing (lactating) women\n* Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months\n* Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).\n* Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception\n* Significant illness within two (2) weeks prior to initial dosing\n* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.\n* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.'}, 'identificationModule': {'nctId': 'NCT01632358', 'briefTitle': 'Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia', 'orgStudyIdInfo': {'id': 'CTAP311X2201'}, 'secondaryIdInfos': [{'id': '2012-000857-29'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP311 capsules', 'description': 'Patients will receive TAP311 capsule orally once daily for 14 days.', 'interventionNames': ['Drug: TAP311 capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of TAP311 capsules', 'description': 'Matching placebo to TAP311 capsule, once daily for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TAP311 capsules', 'type': 'DRUG', 'armGroupLabels': ['TAP311 capsules']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo of TAP311 capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '11941', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '40447', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}