Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04045405
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2019-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess Safety, PK and PD Parameters of CDR132L
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events [safety and tolerability]', 'timeFrame': '4 months', 'description': 'The incidence and severity of treatment-emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax)'}, {'measure': 'Time to reach maximum plasma concentration (Tmax)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)'}, {'measure': 'Area under the curve (AUC0-t)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t)'}, {'measure': 'Area under the curve (AUC0-inf)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)'}, {'measure': 'Blood clearance (CL)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter to determin clearance considering terminal elimination rate'}, {'measure': 'Half life (t1/2)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter to determin half-life rate (t1/2)'}, {'measure': 'Volume of distribution (Vdss)', 'timeFrame': '4 months', 'description': 'Pharmacokinetics parameter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33245749', 'type': 'DERIVED', 'citation': 'Taubel J, Hauke W, Rump S, Viereck J, Batkai S, Poetzsch J, Rode L, Weigt H, Genschel C, Lorch U, Theek C, Levin AA, Bauersachs J, Solomon SD, Thum T. Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study. Eur Heart J. 2021 Jan 7;42(2):178-188. doi: 10.1093/eurheartj/ehaa898.'}, {'pmid': '32105576', 'type': 'DERIVED', 'citation': 'Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).', 'detailedDescription': 'Objectives:\n\nPrimary\n\n• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).\n\nSecondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.\n\nExploratory\n\n• To determine the effect of CDR132L on pharmacodynamic (PD) parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable heart failure of ischemic origin\n\nExclusion Criteria:\n\n* Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),'}, 'identificationModule': {'nctId': 'NCT04045405', 'briefTitle': 'Clinical Study to Assess Safety, PK and PD Parameters of CDR132L', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardior Pharmaceuticals GmbH'}, 'officialTitle': 'Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)', 'orgStudyIdInfo': {'id': 'CDR132L-FIH01'}, 'secondaryIdInfos': [{'id': '2019-001291-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDR132L', 'interventionNames': ['Drug: CDR132L']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: CDR132L']}], 'interventions': [{'name': 'CDR132L', 'type': 'DRUG', 'description': 'i.v. administration', 'armGroupLabels': ['CDR132L', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Wilfried Hauke, MD MFPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardior Pharmaceuticals GmbH CMO'}, {'name': 'Jorg Taubel, MD FFPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Richmond Pharmacology Ltd CEO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardior Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}