Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 12:15 PM
Study NCT ID:
NCT04461756
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of adverse events [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'To evaluate treatment-related adverse events of PPP001'}, {'measure': 'Biochemistry test results [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase'}, {'measure': 'Temperature [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'Oral temperature in Celsius'}, {'measure': 'Pulse rate [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'Pulse rate (in beats per minute)'}, {'measure': 'Blood pressure [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'Blood pressure (systolic/diastolic blood pressure in mm Hg)'}, {'measure': 'Clinically significant ECG abnormalities [Safety and Tolerability]', 'timeFrame': 'over 5 days', 'description': 'Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)'}, {'measure': 'Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)', 'timeFrame': 'over 5 days'}, {'measure': 'Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)', 'timeFrame': 'over 5 days'}, {'measure': 'Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)', 'timeFrame': 'over 5 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volonteers']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.\n\nThe secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index within 21.0 to 32.0 kg/m2, inclusively\n* A light-, non- or ex-smoker of nicotine\n* A history of recreational cannabis use (at least 10 times in the last 5 years)\n* Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study\n* Presence of intact oral mucosa\n* Able to follow instructions at the training vaporizing session\n* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator\n* No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ECG, as determined by an investigator"}, 'identificationModule': {'nctId': 'NCT04461756', 'briefTitle': 'Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tetra Bio-Pharma'}, 'officialTitle': 'A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers', 'orgStudyIdInfo': {'id': 'PPP001-Ph1-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'inhaled THC/CBD (PPP001)', 'interventionNames': ['Drug: PPP001']}], 'interventions': [{'name': 'PPP001', 'type': 'DRUG', 'description': 'inhalation (vape)', 'armGroupLabels': ['inhaled THC/CBD (PPP001)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Alta sciences', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tetra Bio-Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Algorithme Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}