A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
NCT Number: NCT06578455
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: CBD Pharmacokinetics|Healthy Participants
Interventions: DRUG: Cannabidiol (CBD) Powder|DRUG: Cannabidiol 100 MG/ML [Epidiolex]
Sponsor: DSM Nutritional Products, Inc.
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2024-12
Locations: Nutrasource Site (Apex Trials), Guelph, Ontario, N1G0B4, Canada

Summary:
Cannabidiol (CBD), derived from the Cannabis sativa plant, is being investigated for its potential health benefit without the psychoactive properties and adverse reactions that arise from the use of delta-9-tetrahydrocannabinol (Δ9-THC). Few studies have characterized the pharmacokinetic (PK) effects and safety of oral CBD administration. Epidiolex (Epidyolex), an oil form of CBD, is the only marketed monotherapy approved by the United States Food and Drug Administration (FDA) and Health Canada. Delivery of a CBD in a powder/capsule form may provide a more efficient method for consumers.

The goal of this study is to characterize the PK profile of the test product, CBD-NE (a capsule formulation) compared to Epidyolex under both fasted and fed conditions. Each participant will receive a dose of each product under both fed and fasted conditions in a crossover design.

Primary Outcome Measures: Pharmacokinetic (PK) Properties of CBD-NE compared to Epidyolex under Fed Conditions, Area under the plasma concentration-time curve over 24 hours (AUC0-24) for CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, AUC0-24 for CBD, 0-24 hours
Secondary Outcome Measures: PK Properties of CBD-NE compared to Epidiolex under Fed Conditions, AUC0-24 for 7-hydroxycannabidiol (7-OH-CBD) and cannabidiol-7-oic acid (7-COOH-CBD), 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, AUC0-24 for 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fed Conditions, Maximum concentration in plasma (Cmax) for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, Cmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fed Conditions, Time to reach Cmax (Tmax) for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, Tmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fed Conditions, Elimination half-life (T1/2) for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, T1/2 for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fed Conditions, Area under the plasma concentration-time curve from zero to infinity (AUCinf) for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fed Conditions, Ratio of AUC0-24 to AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions, Ratio of AUC0-24 to AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Total Drug Exposure of CBD-NE compared to Epidyolex under Fed Conditions, Sum of AUC0-24 of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Total Drug Exposure of CBD-NE compared to Epidyolex under Fasted Conditions, Sum of AUC0-24 of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Total Drug Exposure of CBD-NE compared to Epidyolex under Fed Conditions, Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Total Drug Exposure of CBD-NE compared to Epidyolex under Fasted Conditions, Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours
Other Outcome Measures: Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, AUC0-24 for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, AUC0-24 for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, Cmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, Cmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, Tmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, Tmax for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, T1/2 for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, T1/2 for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions, Ratio of AUC0-24 to AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions, Ratio of AUC0-24 to AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of Total Drug Exposure of CBD-NE under Fed and Fasted Conditions, Sum of AUC0-24 of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of Total Drug Exposure of Epidyolex under Fed and Fasted Conditions, Sum of AUC0-24 of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of Total Drug Exposure of CBD-NE under Fed and Fasted Conditions, Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Comparison of Total Drug Exposure of Epidyolex under Fed and Fasted Conditions, Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD, 0-24 hours|Assessment of 12-lead electrocardiogram (ECG), Change from pre-dose to 12 h in QRS interval as assessed by 12-lead ECG, 12 hours|Assessment of 12-lead electrocardiogram (ECG), Change from pre-dose to 12 h in heart rate as assessed by 12-lead ECG, 12 hours|Assessment of 12-lead electrocardiogram (ECG), Change from pre-dose to 12 h in PR interval as assessed by 12-lead ECG, 12 hours|Assessment of 12-lead electrocardiogram (ECG), Change from pre-dose to 12 h in QT interval as assessed by 12-lead ECG, 12 hours|Heart rate, Change from pre-dose to post-dose in heart rate (beats per minute), 0-24 hours|Blood pressure, Change from pre-dose to post-dose in systolic and diastolic blood pressure (mm Hg), 0-24 hours|Respiratory rate, Change from pre-dose to 24 h in respiratory rate (breaths per minute), 0-24 hours|Body Temperature, Change from pre-dose to 24 h in body temperature (°C), 0-24 hours|Composite Measure of Physical Abnormalities Observed in A Comprehensive Physical Exam, Presence or absence of physical abnormalities in general appearance, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of ears, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of eyes, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of nose, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of throat, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of skin, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of chest, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of lungs, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of abdomen, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of physical abnormalities of lymph nodes, 12 hours|Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam, Presence or absence of neurological abnormalities, 12 hours|Incidence of Adverse Events, Number of participants with adverse events, minimum of 14 days, maximum of 28 days|Whole Blood Hemoglobin, Change from pre-dose in whole blood hemoglobin (g/dL), 12 hours|Whole Blood Hematocrit, Change from pre-dose in whole blood hematocrit (%), 12 hours|Whole Blood White Blood Cells, Change from pre-dose in whole blood white blood cells (x10\^3/uL), 12 hours|Whole Blood Neutrophils, Change from pre-dose in whole blood neutrophils (cells/uL), 12 hours|Whole Blood Eosinophils, Change from pre-dose in whole blood eosinophils (cells/uL), 12 hours|Whole Blood Basophils, Change from pre-dose in whole blood basophils (cells/uL), 12 hours|Whole Blood Lymphocytes, Change from pre-dose in whole blood lymphocytes (cells/uL), 12 hours|Whole Blood Monocytes, Change from pre-dose in whole blood monocytes (cells/uL), 12 hours|Whole Blood Mean Platelet Volume, Change from pre-dose in whole blood mean platelet volume (fL), 12 hours|Whole Blood Platelet Count, Change from pre-dose in whole blood platelet count (x10\^9/L), 12 hours|Whole Blood Red Blood Cell Count, Change from pre-dose in whole blood red blood cell count (x10\^6/uL), 12 hours|Whole Blood Red Blood Cell Distribution Width, Change from pre-dose in whole blood red blood cell distribution width (%), 12 hours|Whole Blood Mean Corpuscular Volume, Change from pre-dose in whole blood mean corpuscular volume (fL), 12 hours|Whole Blood Mean Corpuscular Hemoglobin, Change from pre-dose in whole blood mean corpuscular hemoglobin (pg), 12 hours|Whole Blood Mean Corpuscular Hemoglobin Concentration, Change from pre-dose in whole blood mean corpuscular hemoglobin concentration (g/dL), 12 hours|Serum Sodium, Change from pre-dose in serum sodium (mmol/L), 12 hours|Serum Potassium, Change from pre-dose in serum potassium (mmol/L), 12 hours|Serum Chloride, Change from pre-dose in serum chloride (mmol/L), 12 hours|Serum Urea, Change from pre-dose in serum urea (mg/dL), 12 hours|Serum Creatinine, Change from pre-dose in serum creatinine (umol/L), 12 hours|Serum Estimated Glomerular Filtration, Change from pre-dose in serum estimated glomerular filtration rate (mL/min/1.73\^2), 12 hours|Serum Total Protein, Change from pre-dose in serum total protein (g/dL), 12 hours|Serum Albumin, Change from pre-dose in serum albumin (g/dL), 12 hours|Serum Globulin, Change from pre-dose in serum globulin (g/dL), 12 hours|Serum Total Bilirubin, Change from pre-dose in serum total bilirubin (mg/dL), 12 hours|Serum Glucose, Change from pre-dose in serum glucose concentration (mg/dL), 12 hours|Serum Alanine Transaminase, Change from pre-dose in serum alanine transaminase concentration (U/L), 12 hours|Serum Aspartate Transaminase, Change from pre-dose in serum aspartate transaminase concentration (U/L), 12 hours|Serum Alkaline Phosphatase, Change from pre-dose in serum alkaline phosphatase concentration (U/L), 12 hours|Gamma Glutamyl Transferase, Change from pre-dose in serum gamma glutamyl transferase concentration (U/L), 12 hours