Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2026-03-20 @ 1:01 AM
Study NCT ID:
NCT00568594
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'dispFirstSubmitDate': '2012-10-22', 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2007-12-05', 'dispFirstSubmitQcDate': '2012-10-22', 'studyFirstSubmitQcDate': '2007-12-05', 'dispFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability, pharmacokinetics and effects on biomarkers of HDL function of APL180 after a single and 7-daily infusions in healthy volunteers (HV) and in patients with coronary heart disease (CHD)', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic/pharmacodynamic relationship after a single and 7 daily infusions in CHD patients', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Apolipoprotein A-I,', 'Atherosclerosis,', 'HDL,', 'Inflammation,'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3320', 'label': 'Results for CAPL180A2201 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female healthy volunteers (ages 18-55 years) and patients with CHD (ages 18 to 75 years) on stable statin therapy for at least 8 weeks, with normal liver and kidney function.\n* Women who are post-menopausal, surgically sterile, or practicing effective contraception. Additional birth control details to be provided at screening.\n* Body mass index (BMI) must be within the range of 20 to 35 for CHD patients or CHD equivalents.\n* Clinical CHD:\n* Myocardial infarction (MI), angina, revascularization (e.g. CABG, stent) at least 6 months prior to inclusion\n* CHD equivalents:\n* symptomatic carotid artery disease (e.g. transient ischemic attack or stroke of carotid origin) or peripheral artery disease or abdominal aortic aneurysm or Diabetes Mellitus (HbA1c ≤9)\n* 20% 10 year risk of CHD (Framingham point score: ≥16 (men), ≥23 (women))\n* Other clinical forms of atherosclerotic disease including \\>50 percent stenosis on angiography or ultrasound\n* Male subjects, when sexually active, using one form of highly effective contraception (e.g. condom)\n\nExclusion Criteria for both healthy volunteers and patients:\n\n* Smokers (use of tobacco products in the previous 3 months). Smokers who report cigarette use of more then 10 cigarette per day or have a urinary cotinine level greater then 500 ng/ml.\n* Pregnancy.\n* Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Significant illness within two weeks prior to dosing.\n* Significant illness within two weeks prior to dosing.\n* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.\n* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug or any allergic reaction to prior receipt of protein therapies or vaccines.\n* Presence of NYHA Class III or IV CHF or unstable angina pectoris.\n* MI or within angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to dosing.\n* Use of certain medications prohibited by the protocol.\n* Uncontrolled diabetes (HbA1c \\> 9).\n* Uncontrolled hypertension (Systolic BP \\>160 mm Hg and/or Diastolic BP \\>100 mmHg on two consecutive measurements).\n* Liver or kidney disease confirmed by abnormal lab values or function.\n* Serum creatine kinase CK (CPK) total \\> 2x.\n* CHD equivalent patients with a history of early positive exercise stress test.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00568594', 'briefTitle': 'Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A First-in-human, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose (Healthy Volunteers and CHD Patients) and Multiple Dose (CHD Patients) Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180', 'orgStudyIdInfo': {'id': 'CAPL180A2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: APL180']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'APL180', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Birkeroed', 'country': 'Denmark', 'facility': 'Novartis Investigator Site'}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tzrifin', 'country': 'Israel', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 31.95649, 'lon': 34.84002}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'George', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'NOVARTIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigative site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}