Status:
COMPLETED
A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
Lead Sponsor:
DSM Nutritional Products, Inc.
Collaborating Sponsors:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Conditions:
CBD Pharmacokinetics
Healthy Participants
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief 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 d...
Detailed Description
CBD and Δ9-THC are the most abundant extracts from the Cannabis sativa plant. Δ9-THC is typically associated with psychotropic effects due to its affinity for cannabinoid receptor types 1 and 2. CBD p...
Eligibility Criteria
Inclusion
- Healthy male or female participants who are 19 to 55 years of age (inclusive).
- Have a body mass index (BMI) range of 18.0 - 29.9 kg/m2 (inclusive) and body weight ≥ 50 kg.
- In good general health as deemed by the investigator.
- Naïve to oral or inhaled cannabis or hemp, or light user of oral or inhaled cannabis or hemp products (not more than 2 times per month on average) who have used cannabis for recreational (non-therapeutic) purposes without severe side effects.
- Non-smoker (including nicotine vaping) and have not used any nicotine products (e.g., patches, gums, etc.) for \>3 months prior to the first PK blood draw (Visit 2). Note: A non-smoker is defined as someone who does not habitually/regularly use products containing nicotine.
- Have suitable veins for repeated venipuncture.
- Have systolic blood pressure within 90 to 139 mmHg (inclusive) and diastolic blood pressure within 60 to 89 mmHg (inclusive) at screening and Visit 2.
- Able to consume oil formulation, and swallow pills or capsules whole, and without chewing.
- Agree to follow the restrictions on concomitant treatments listed in the protocol.
- Agree to follow the restrictions on lifestyle listed in the protocol.
- Agree to adhere to the contraception requirements for this study.
- Able to consume the entire high-fat, high-calorie breakfast provided within 30 minutes at the site during Visits 2 and 4.
- Agree to fast overnight, i.e., no food or liquids (except for water, permitted up to 1 h prior to dosing) for a minimum 10 h prior to starting the high-fat, high-calorie breakfast on Visits 2 and 4 or prior to dosing on Visits 6 and 8.
- Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months prior to screening.
- Willing and able to agree to the requirements and restrictions of this study, be willing to voluntarily consent, and carry out all study related procedures.
Exclusion
- Participants who are lactating, pregnant, or planning to become pregnant during the study as confirmed by a positive pregnancy test during study visits or not willing to perform a pregnancy test.
- Male participants that are planning to conceive during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the items that could be included in the standardized meals/snacks.
- Current COVID-19 infection at the time of screening or Visit 2, or currently have the post COVID-19 condition as defined by the World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by alternative diagnosis).
- Presence of any clinically significant or abnormal results from laboratory tests at screening (Visit 1) and/or vital sign assessments at Visits 1 or 2 as judged by the investigator and or/designee.
- Demonstrates a positive screen for Hepatitis B Surface Antigen (HBsAg), Hepatitis C (HCV), or Human Immune Deficiency Virus (HIV) at screening.
- Demonstrates a positive urine drug screen, positive cotinine test or positive breath alcohol test at screening or Visit 2.
- Have abnormal 12-lead electrocardiogram (ECG) results at screening or Visit 2 as determined at the discretion of the investigator.
- Evidence of hepatic or renal dysfunction as evidenced by alanine aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT) being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 176.84 µmol/L at screening.
- Have thyroid disease, Type I or Type II diabetes.
- Have a history of blood clotting disorders.
- Have a history of heart disease/cardiovascular disease, renal or hepatic impairment/ disease, bipolar disorder, immune disorders and/or immunocompromised \[(e.g., HIV/acquired immunodeficiency syndrome (AIDS)\].
- Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit.
- Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Have medical condition(s) known to interfere with absorption, distribution, metabolism or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
- Major surgery with general anesthesia in the 3 months prior to screening or planned major surgery during the study.
- Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to the first PK visit (Visit 2) or a blood donation of more than 450 mL within 56 days prior to Visit 2.
- Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2.
- History of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
- Currently consumes, on average, more than 2 standard alcoholic beverages a day or has any habit of alcohol use that, to the opinion of the investigator, may be of a concern for the study. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
- Receipt or use of test product(s) in another research study within 28 days prior to Visit 2 or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06578455
Start Date
August 30 2024
End Date
December 16 2024
Last Update
December 17 2024
Active Locations (1)
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1
Nutrasource Site (Apex Trials)
Guelph, Ontario, Canada, N1G0B4