Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 11:38 AM
Study NCT ID:
NCT03471559
Status:
TERMINATED
Last Update Posted:
2020-07-01
First Post:
2018-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol - an in Vivo Innovative Drug Delivery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Two step study, step two was not feasible based on results from phase one.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞))', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of single dose - residual area', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of single dose - maximum concentration (Cmax)', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of single dose - time to reach Cmax (tmax)', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of single dose - elimination half life (t1/2)', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of single dose - elimination rate constant (λz)', 'timeFrame': '36 hours', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))', 'timeFrame': '9 days', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)', 'timeFrame': '9 days', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)', 'timeFrame': '9 days', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h))', 'timeFrame': '9 days', 'description': 'reference formulation compared to new formulation'}, {'measure': 'Pharmacokinetic profile of multiple dosing - steady state accumulation ratio', 'timeFrame': '9 days', 'description': 'reference formulation compared to new formulation'}], 'secondaryOutcomes': [{'measure': 'Regular laboratory testing', 'timeFrame': '36h or 9 days', 'description': 'standard laboratory blood tests'}, {'measure': 'Electrocardiography - QTc time', 'timeFrame': '36 hours or 9 days'}, {'measure': 'Vital signs - body temperature', 'timeFrame': '36 hours or 9 days'}, {'measure': 'Vital signs - blood pressure', 'timeFrame': '36 hours or 9 days', 'description': 'Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)'}, {'measure': 'Vital signs - pulse rate', 'timeFrame': '36 hours or 9 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics, Bioavailability']}, 'descriptionModule': {'briefSummary': 'Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.', 'detailedDescription': 'This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent given by the subject\n* Negative drug screening at the time of screening\n* Non-smoking\n* In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.\n* Body Mass Index between 18.5 kg/m2 and 30 kg/m2\n\nExclusion Criteria:\n\n* Lack of accountability\n* Pregnancy or lactation phase in females at the time of screening\n* Any known psychiatric or neurological illness in the participant's history.\n* Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)\n* Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)\n* Consumption of any illicit drugs (except cannabis in history, see above)\n* Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator"}, 'identificationModule': {'nctId': 'NCT03471559', 'briefTitle': 'Cannabidiol - an in Vivo Innovative Drug Delivery Study', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study', 'orgStudyIdInfo': {'id': 'CBD-DDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference formulation', 'description': 'Cannabidiol capsule, 200 mg', 'interventionNames': ['Drug: Cannabidiol']}, {'type': 'EXPERIMENTAL', 'label': 'New formulation', 'description': 'Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study)', 'interventionNames': ['Drug: Cannabidiol']}], 'interventions': [{'name': 'Cannabidiol', 'type': 'DRUG', 'description': 'single or multiple dosing', 'armGroupLabels': ['New formulation', 'Reference formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Department I of Pharmacology, University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Uwe Fuhr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department I of Pharmacology, University of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}