Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT04261166
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'C053396', 'term': 'L 644711'}], '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': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic analysis of Cmax', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of Tlag', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of Tmax', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of AUC(0-t)', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of AUC(0-∞)', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of %AUC extrapolated', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of T1/2', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of clearance from plasma (Cl/F)', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of clearance from plasma dose normalized Cmax', 'timeFrame': '0-12 hours post dose'}, {'measure': 'Pharmacokinetic analysis of dose normalized AUC', 'timeFrame': '0-12 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy, male or female, between 18 and 45 years of age (inclusive).\n2. Body mass index (BMI) between 20-30 kg/m2 (both inclusive)\n3. No recent cannabis usage within 30 days from screening\n4. Normal rage hepatic functions\n5. No electrolytes abnormalities\n6. Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:\n\n 1. Body temperature between 35.0 to 37.5 °C\n 2. Systolic blood pressure, 90 to 150 mmHg\\*\n 3. Diastolic blood pressure, 60 to 90 mmHg\\*\n 4. Pulse rate, 50 to 90 beats per minute\\*.\n 5. \\*Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).\n\nExclusion Criteria:\n\n1. Blood donation within 90 days\n2. History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders\n3. Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study\n4. Pregnant women\n5. Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.\n6. Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP\n7. Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.\n8. Subjects who had postural drop of \\> 20 mmHg in systolic blood pressure at screening\n9. Patients with heart failure,\n10. Subjects with a history of psychotic state in the past or anxiety disorder,\n11. Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member\n12. Subjects with a history of addiction or drug abuse'}, 'identificationModule': {'nctId': 'NCT04261166', 'briefTitle': 'A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract', 'organization': {'class': 'INDUSTRY', 'fullName': 'Breath of Life International Pharma Ltd'}, 'officialTitle': 'A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract', 'orgStudyIdInfo': {'id': 'BOL-PK-ST-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose', 'description': 'Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4', 'interventionNames': ['Drug: A1', 'Drug: A2', 'Drug: A3', 'Drug: A4', 'Drug: A5', 'Drug: B1', 'Drug: B2', 'Drug: B3', 'Drug: B4']}, {'type': 'EXPERIMENTAL', 'label': 'Cross-Over food effect', 'description': '2 doses: fasted and fed state with the same product: A1, A4, A5, B4', 'interventionNames': ['Drug: A1', 'Drug: A4', 'Drug: A5', 'Drug: B4']}, {'type': 'EXPERIMENTAL', 'label': 'Cross-Over product comparison', 'description': '2 doses: in fasted state comparing A1 to A4', 'interventionNames': ['Drug: A1', 'Drug: A4']}, {'type': 'EXPERIMENTAL', 'label': 'Cross-over route of administration comparison', 'description': '2 doses: in fasted state comparing oral administration to sublingual administration of A4', 'interventionNames': ['Drug: A4']}], 'interventions': [{'name': 'A1', 'type': 'DRUG', 'otherNames': ['Celixir 20 T1/C20- CBD 20%, THC 1%'], 'description': 'Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)', 'armGroupLabels': ['Cross-Over food effect', 'Cross-Over product comparison', 'Single dose']}, {'name': 'A2', 'type': 'DRUG', 'otherNames': ['Telixir 10 T2/C10 - CBD 2%, THC 10%'], 'description': 'Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)', 'armGroupLabels': ['Single dose']}, {'name': 'A3', 'type': 'DRUG', 'otherNames': ['Equatir 10 T10/C10 - CBD 10%, THC 10%'], 'description': 'Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)', 'armGroupLabels': ['Single dose']}, {'name': 'A4', 'type': 'DRUG', 'otherNames': ['C18T0.9 in MCT oil - CBD 18%, THC 0.9%'], 'description': 'Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)', 'armGroupLabels': ['Cross-Over food effect', 'Cross-Over product comparison', 'Cross-over route of administration comparison', 'Single dose']}, {'name': 'A5', 'type': 'DRUG', 'otherNames': ['T10/C2 - CBD 2%, THC 10%'], 'description': 'Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)', 'armGroupLabels': ['Cross-Over food effect', 'Single dose']}, {'name': 'B1', 'type': 'DRUG', 'otherNames': ['Tablet: CBD 40 mg, THC 2 mg'], 'description': 'Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)', 'armGroupLabels': ['Single dose']}, {'name': 'B2', 'type': 'DRUG', 'otherNames': ['Tablet: CBD 30 mg, THC 5 mg'], 'description': 'Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)', 'armGroupLabels': ['Single dose']}, {'name': 'B3', 'type': 'DRUG', 'otherNames': ['Tablet: CBD 40 mg'], 'description': 'Sublingual tablets. CBD 40 mg (1 tablet)', 'armGroupLabels': ['Single dose']}, {'name': 'B4', 'type': 'DRUG', 'otherNames': ['Tablet: CBD 40 mg'], 'description': 'Sublingual tablets. CBD 40 mg (1 tablet)', 'armGroupLabels': ['Cross-Over food effect', 'Single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Breath of Life International Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}