Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT01487460
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], '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': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia', 'timeFrame': 'Up to 21 days', 'description': 'Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).'}], 'secondaryOutcomes': [{'measure': 'TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.', 'timeFrame': '25 timepoints over 17 days'}, {'measure': 'Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.', 'timeFrame': '10 days', 'description': 'Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.'}, {'measure': 'Effect of food on TAP311 blood concentration in healthy subjects.', 'timeFrame': '3 days', 'description': 'TAP311 blood concentration when the drug is administered with and without food.'}, {'measure': 'Effects of TAP311 on total cholesterol in patients with dyslipidemia', 'timeFrame': '8 timepoints over 15 days', 'description': 'Total cholesterol blood concentration before and after TAP311 treatment.'}, {'measure': 'Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia', 'timeFrame': '8 timepoints over 15 days', 'description': 'LDL-C blood concentration before and after TAP311 treatment.'}, {'measure': 'Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.', 'timeFrame': '8 timepoints over 15 days', 'description': 'HDL-C blood concentration before and after TAP311 treatment.'}, {'measure': 'Effects of TAP311 on triglycerides in patients with Dyslipidemia', 'timeFrame': '8 timepoints over 15 days', 'description': 'Triglycerides concentration in blood before and after TAP311 treatment.'}]}, 'conditionsModule': {'keywords': ['High cholesterol levels', 'Hyperlipidemia', 'High-density Lipoprotein', 'Low-density Lipoprotein', 'Simvastatin'], 'conditions': ['Dyslipidemia', 'Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9083', 'label': 'Results for CTAP311X2101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.\n* OR untreated dyslipidemic patients.\n* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment.\n* Active treatment for type 1 diabetes or type 2 diabetes mellitus.\n* A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.\n* History of malignancy of any organ system, treated or untreated, within the past 5 years.\n* Pregnant or nursing (lactating) women.\n* Smokers.\n* Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements.\n* History of drug or alcohol abuse within the 12 months prior to dosing.\n* Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01487460', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.', 'orgStudyIdInfo': {'id': 'CTAP311X2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP311 in Healthy Volunteers', 'interventionNames': ['Drug: TAP311']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Healthy Volunteers and Patients will be treated in Placebo group.', 'interventionNames': ['Drug: TAP311']}, {'type': 'EXPERIMENTAL', 'label': 'TAP311 and Simvastatin', 'interventionNames': ['Drug: TAP311']}, {'type': 'EXPERIMENTAL', 'label': 'TAP311 in Patients', 'interventionNames': ['Drug: TAP311']}], 'interventions': [{'name': 'TAP311', 'type': 'DRUG', 'armGroupLabels': ['Matching Placebo', 'TAP311 and Simvastatin', 'TAP311 in Healthy Volunteers', 'TAP311 in Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}