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CBD PharmacokineticsPhase 1NCT06578455

A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

A Phase 1 study testing Cannabidiol (CBD) Powder and Cannabidiol 100 MG/ML [Epidiolex] in people with CBD Pharmacokinetics and Healthy Participants, run by dsm-firmenich Switzerland AG at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
CBD Pharmacokinetics, Healthy Participants
What is being tested?
Cannabidiol (CBD) Powder and Cannabidiol 100 MG/ML [Epidiolex]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
30 Aug 2024to 16 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Nutrasource Site (Apex Trials)

    Guelph, Ontario, N1G0B4

Other trials in Canada

About this study

Official title: A Randomized, Open-Label, 4-Way Crossover, Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

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.

Read the 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 possesses a low affinity and lack of function at these receptors; therefore there is an interest in its potential health benefit without the psychoactive properties and adverse reactions that arise from Δ9-THC use. Only few studies have characterized the PK effects and the safety of oral CBD administration. As CBD is a lipophilic molecule, consuming CBD with a lipid formulation may increase its exposure. Additionally, CBD is known to have poor bioavailability when taken orally because it is rapidly metabolized by the liver to 7-hydroxycannabidiol (7-OH-CBD) and then to cannbidiol-7-oic acid (7-COOH-CBD), which may reduce the potency of CBD. Formulation strategies for orally consumed CBD products are being investigated to by-pass one or both of these limitations and improve the bioavailability of CBD. Epidyolex, a purified form of CBD, is delivered in a solution of sesame oil which aids absorption. Epidyolex, marketed and sold in the US and Canada as Epidiolex, is currently the only marketed CBD monotherapy with US FDA and Health Canada approval and is approved for treatment of certain types of epilepsy. However, administration of CBD in oil form is not ideal for consumers as it is not always convenient or precise. Delivery of CBD in a powder/capsule form may provide a more efficient method of CBD consumption.

The test product will be CBD-NE, a novel formulation of CBD in a powder form. This product will be investigated in healthy adults as its PK profile is not yet characterized in humans. This study is designed to be a randomized, crossover, comparator control trial to evaluate the PK profile and safety of CBD-NE compared to Epidyolex in healthy adults under both fed and fasted conditions.

Two study products, CBD-NE and Epidyolex, will be administered under both fed and fasted conditions. Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment sequences. There will be a total of 4 treatment periods consisting of 2 consecutive days, and one washout period. Each dose will be followed by a minimum 14-day, maximum of 28-day washout period, with the last dose followed by a follow-up phone call which will occur within the timeframe of the longest washout period over the study. For the fed state, participants will consume a high-fat, high-calorie breakfast within the 30 minutes prior to dosing.

Pharmacokinetic blood sampling will occur pre-dose and at 0.25 h, 0.5 h, 0.75 h, 1.0 h, 1.5 h, 2.0 h, 3.0 h, 4.0 h, 5.0 h, 6.0 h, 8.0 h, 12.0 h and 24.0 h post-dose.

Blood samples collected will be used to assess the PK profiles of CBD-NE and Epidyolex. PK parameters measured will include maximum concentration in plasma (Cmax), time to reach maximum concentration (Tmax), elimination half-life (T1/2), area under the plasma concentration-time curve over 24 hours (AUC0-24), area under the plasma concentration-time curve from zero to infinity (AUCinf) and AUC0-24/AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD. Safety endpoints will be assessed throughout the study and will include reports of adverse events, 12-lead ECG, vital signs, safety laboratory assessments, and abbreviated physical exam.

Being tested
Cannabidiol (CBD) Powder, Cannabidiol 100 MG/ML [Epidiolex]
Keywords
Cannabidiol, Pharmacokinetic, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol (CBD) PowderDrug

    Also called CBD-NE

    66.68 mg CBD per capsule for a total of 400 mg CBD per serving

  • Cannabidiol 100 MG/ML [Epidiolex]Drug

    Also called Epidyolex

    100 mg CBD/mL for a total of 400 mg CBD per serving

Study groups in NCT06578455
Study groupRoleWhat they receive
CBD-NE Under Fed ConditionExperimentalA single dose of CBD-NE (6 capsules) following consumption of a high-fat, high-calorie breakfast
Receives: Drug: Cannabidiol (CBD) Powder
TP Under Fasted ConditionExperimentalA single dose of CBD-NE (6 capsules) after a minimum 10-hour fast
Receives: Drug: Cannabidiol (CBD) Powder
Epidyolex Under Fed ConditionActive comparatorA single dose of Epidyolex (4 mL oil) following consumption of a high-fat, high-calorie breakfast
Receives: Drug: Cannabidiol 100 MG/ML [Epidiolex]
Epidyolex Under Fasted ConditionActive comparatorA single dose of Epidyolex (4 mL oil) after a minimum 10-hour fast
Receives: Drug: Cannabidiol 100 MG/ML [Epidiolex]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0-24 hours

  2. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    AUC0-24 for CBD

    Measured: 0-24 hours

Secondary outcomes (16)

  1. 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)

    Measured: 0-24 hours

  2. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    AUC0-24 for 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  3. 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

    Measured: 0-24 hours

  4. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    Cmax for CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  5. 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

    Measured: 0-24 hours

  6. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    Tmax for CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  7. 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

    Measured: 0-24 hours

  8. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    T1/2 for CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  9. 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

    Measured: 0-24 hours

  10. PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions

    AUCinf for CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  11. 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

    Measured: 0-24 hours

  12. 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

    Measured: 0-24 hours

  13. 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

    Measured: 0-24 hours

  14. 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

    Measured: 0-24 hours

  15. Total Drug Exposure of CBD-NE compared to Epidyolex under Fed Conditions

    Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

  16. Total Drug Exposure of CBD-NE compared to Epidyolex under Fasted Conditions

    Sum of AUCinf of CBD, 7-OH-CBD and 7-COOH-CBD

    Measured: 0-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion20 Nov 2024
  4. Study completion16 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, Open-Label, Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578455
Sponsor's protocol ID
T0051
Status last verified
Sep 2024
First submitted
20 Aug 2024
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Legare CA, Raup-Konsavage WM, Vrana KE. Therapeutic Potential of Cannabis, Cannabidiol, and Cannabinoid-Based Pharmaceuticals. Pharmacology. 2022;107(3-4):131-149. doi: 10.1159/000521683. Epub 2022 Jan 28.

    PubMed 35093949

  • Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

    PubMed 28538134

  • Knaub K, Sartorius T, Dharsono T, Wacker R, Wilhelm M, Schon C. A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorb(R) Formulation Technology Improving the Oral Bioavailability of Cannabidiol in Healthy Subjects. Molecules. 2019 Aug 16;24(16):2967. doi: 10.3390/molecules24162967.

    PubMed 31426272

  • Huestis MA, Solimini R, Pichini S, Pacifici R, Carlier J, Busardo FP. Cannabidiol Adverse Effects and Toxicity. Curr Neuropharmacol. 2019;17(10):974-989. doi: 10.2174/1570159X17666190603171901.

    PubMed 31161980

  • Berl V, Hurd YL, Lipshutz BH, Roggen M, Mathur EJ, Evans M. A Randomized, Triple-Blind, Comparator-Controlled Parallel Study Investigating the Pharmacokinetics of Cannabidiol and Tetrahydrocannabinol in a Novel Delivery System, Solutech, in Association with Cannabis Use History. Cannabis Cannabinoid Res. 2022 Dec;7(6):777-789. doi: 10.1089/can.2021.0176. Epub 2022 Jul 5.

    PubMed 35787693

  • Taylor L, Gidal B, Blakey G, Tayo B, Morrison G. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects. CNS Drugs. 2018 Nov;32(11):1053-1067. doi: 10.1007/s40263-018-0578-5.

    PubMed 30374683

  • Abbotts KSS, Ewell TR, Butterklee HM, Bomar MC, Akagi N, Dooley GP, Bell C. Cannabidiol and Cannabidiol Metabolites: Pharmacokinetics, Interaction with Food, and Influence on Liver Function. Nutrients. 2022 May 21;14(10):2152. doi: 10.3390/nu14102152.

    PubMed 35631293

  • Britch SC, Babalonis S, Walsh SL. Cannabidiol: pharmacology and therapeutic targets. Psychopharmacology (Berl). 2021 Jan;238(1):9-28. doi: 10.1007/s00213-020-05712-8. Epub 2020 Nov 21.

    PubMed 33221931

  • Peng J, Fan M, An C, Ni F, Huang W, Luo J. A narrative review of molecular mechanism and therapeutic effect of cannabidiol (CBD). Basic Clin Pharmacol Toxicol. 2022 Apr;130(4):439-456. doi: 10.1111/bcpt.13710. Epub 2022 Feb 6.

    PubMed 35083862

  • Bendik I, Beck M, Manderna A, Roos FF, Wang J, McCarthy D, Schweiggert C, Besheer A, Baisley J, Misic Z, Mussler B, Kuttenkeuler A, Piomelli D, Peter S. Comparative Pharmacokinetics and Safety of Cannabidiol in a Powder Formulation, CBtru(R), vs an Oil-Based Formulation, Epidyolex(R), Under Fasted and Fed Conditions in Healthy Participants: A Randomized Open-Label Cross-Over Phase I Study. CNS Drugs. 2026 May;40(5):709-723. doi: 10.1007/s40263-026-01280-1. Epub 2026 Mar 26.

    PubMed 41888503

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cannabidiol (CBD) Powder and Cannabidiol 100 MG/ML [Epidiolex] in people with CBD Pharmacokinetics and Healthy Participants, run by dsm-firmenich Switzerland AG at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Properties of CBD-NE compared to Epidyolex under Fed Conditions (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06578455, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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