Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT01554800
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2012-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2012-03-13', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Participants Experience with Safety and Tolerability', 'timeFrame': 'Day 1 to Day 28', 'description': 'Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile', 'timeFrame': 'Hours 0, 1, 6, 12, 24, 48, 72, 96, 168'}, {'measure': 'Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose', 'timeFrame': 'Hours 0, 1, 6, 12, 24, 48, 72, 96, 168'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lecithin Cholesterol Acyl Transferase', 'LCAT', 'rhLCAT', 'Enzyme replacement therapy', 'High-Density Lipoprotein (HDL)', 'Cholesterol', 'Cholesterol ester', 'LCAT Deficiency'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '26628614', 'type': 'DERIVED', 'citation': 'Shamburek RD, Bakker-Arkema R, Shamburek AM, Freeman LA, Amar MJ, Auerbach B, Krause BR, Homan R, Adelman SJ, Collins HL, Sampson M, Wolska A, Remaley AT. Safety and Tolerability of ACP-501, a Recombinant Human Lecithin:Cholesterol Acyltransferase, in a Phase 1 Single-Dose Escalation Study. Circ Res. 2016 Jan 8;118(1):73-82. doi: 10.1161/CIRCRESAHA.115.306223. Epub 2015 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.', 'detailedDescription': 'After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of stable documented CAD\n* Currently non-smoking males and females ages 30 to 85 years inclusive.\n\n o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.\n* Chronic concomitant medications must be stable for at least 2 months prior to screening\n* HDL-C \\< 50 mg/dL for men and \\< 55 mg/dL for women\n* Body Mass Index (BMI) of approximately 18 to 35 kg/m\\^2; and a total body weight \\>= 50 kg (110 lbs) and \\<= 110 kg (approximately 242 lbs)\n\nExclusion Criteria:\n\n* Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.\n* Chronic heart failure (\\> New York Heart Association (NYHA) Functional Classification II).\n* Ventricular tachyarrhythmias.\n* Uncontrolled Type 2 (HbA1c \\> 8.5%) or Type 1 diabetes mellitus.\n* History of febrile illness within 5 days prior to dosing.\n* History of regular alcohol consumption exceeding 10 drinks per week.\n* 12-lead ECG demonstrating QTc \\> 500 msec at screening.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.'}, 'identificationModule': {'nctId': 'NCT01554800', 'briefTitle': 'Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'An Intravenous, Open-label, Single-dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of rhLCAT in Subjects With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'ACP 501-01'}, 'secondaryIdInfos': [{'id': '12-H-0092', 'type': 'OTHER', 'domain': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACP-501', 'interventionNames': ['Drug: ACP-501']}], 'interventions': [{'name': 'ACP-501', 'type': 'DRUG', 'description': 'A single dose infusion', 'armGroupLabels': ['ACP-501']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cardiovascular and Pulmonary Branch (CPB) of NIH', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}