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CompletedNCT06578455Updated Dec 17, 2024

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

A Phase 1 interventional study of Cannabidiol (CBD) Powder and Cannabidiol 100 MG/ML [Epidiolex] in CBD Pharmacokinetics and Healthy Participants, sponsored by DSM Nutritional Products, Inc.. Completed at 1 site in Canada. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by DSM Nutritional Products, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • CBD Pharmacokinetics
  • Healthy Participants

Keywords

  • Cannabidiol
  • Pharmacokinetic
  • Safety
03

In context

Lead sponsor

DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male or female participants who are 19 to 55 years of age (inclusive).
  2. Have a body mass index (BMI) range of 18.0 - 29.9 kg/m2 (inclusive) and body weight ≥ 50 kg.
  3. In good general health as deemed by the investigator.
  4. 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.
  5. 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.
  6. Have suitable veins for repeated venipuncture.
  7. 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.
  8. Able to consume oil formulation, and swallow pills or capsules whole, and without chewing.
  9. Agree to follow the restrictions on concomitant treatments listed in the protocol.
  10. Agree to follow the restrictions on lifestyle listed in the protocol.
  11. Agree to adhere to the contraception requirements for this study.
  12. Able to consume the entire high-fat, high-calorie breakfast provided within 30 minutes at the site during Visits 2 and 4.
  13. 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.
  14. Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months prior to screening.
  15. 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 criteria

Exclusion Criteria:

  1. 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.
  2. Male participants that are planning to conceive during the study.
  3. 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.
  4. 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).
  5. 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.
  6. Demonstrates a positive screen for Hepatitis B Surface Antigen (HBsAg), Hepatitis C (HCV), or Human Immune Deficiency Virus (HIV) at screening.
  7. Demonstrates a positive urine drug screen, positive cotinine test or positive breath alcohol test at screening or Visit 2.
  8. Have abnormal 12-lead electrocardiogram (ECG) results at screening or Visit 2 as determined at the discretion of the investigator.
  9. 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.
  10. Have thyroid disease, Type I or Type II diabetes.
  11. Have a history of blood clotting disorders.
  12. 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)].
  13. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit.
  14. 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).
  15. 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).
  16. Major surgery with general anesthesia in the 3 months prior to screening or planned major surgery during the study.
  17. 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.
  18. Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2.
  19. 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).
  20. 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.
  21. 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.
  22. 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    CBD-NE Under Fed Condition

    A single dose of CBD-NE (6 capsules) following consumption of a high-fat, high-calorie breakfast

    Drug: Cannabidiol (CBD) Powder

  • Experimental
    TP Under Fasted Condition

    A single dose of CBD-NE (6 capsules) after a minimum 10-hour fast

    Drug: Cannabidiol (CBD) Powder

  • Active comparator
    Epidyolex Under Fed Condition

    A single dose of Epidyolex (4 mL oil) following consumption of a high-fat, high-calorie breakfast

    Drug: Cannabidiol 100 MG/ML [Epidiolex]

  • Active comparator
    Epidyolex Under Fasted Condition

    A single dose of Epidyolex (4 mL oil) after a minimum 10-hour fast

    Drug: Cannabidiol 100 MG/ML [Epidiolex]

Interventions

  • DrugCannabidiol (CBD) Powder

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

    Also known as: CBD-NE

  • DrugCannabidiol 100 MG/ML [Epidiolex]

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

    Also known as: Epidyolex

06

What researchers measure

Primary outcomes

  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

    Time frame: 0-24 hours

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

    AUC0-24 for CBD

    Time frame: 0-24 hours

Secondary outcomes

  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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 0-24 hours

Other outcomes

  1. Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  2. Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  3. Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  4. Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  5. Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  6. Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  7. Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  8. Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  9. Comparison of PK Properties of CBD-NE under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  10. Comparison of PK Properties of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  11. 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

    Time frame: 0-24 hours

  12. 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

    Time frame: 0-24 hours

  13. 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

    Time frame: 0-24 hours

  14. 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

    Time frame: 0-24 hours

  15. 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

    Time frame: 0-24 hours

  16. Comparison of Total Drug Exposure of Epidyolex under Fed and Fasted Conditions

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

    Time frame: 0-24 hours

  17. Assessment of 12-lead electrocardiogram (ECG)

    Change from pre-dose to 12 h in QRS interval as assessed by 12-lead ECG

    Time frame: 12 hours

  18. Assessment of 12-lead electrocardiogram (ECG)

    Change from pre-dose to 12 h in heart rate as assessed by 12-lead ECG

    Time frame: 12 hours

  19. Assessment of 12-lead electrocardiogram (ECG)

    Change from pre-dose to 12 h in PR interval as assessed by 12-lead ECG

    Time frame: 12 hours

  20. Assessment of 12-lead electrocardiogram (ECG)

    Change from pre-dose to 12 h in QT interval as assessed by 12-lead ECG

    Time frame: 12 hours

  21. Heart rate

    Change from pre-dose to post-dose in heart rate (beats per minute)

    Time frame: 0-24 hours

  22. Blood pressure

    Change from pre-dose to post-dose in systolic and diastolic blood pressure (mm Hg)

    Time frame: 0-24 hours

  23. Respiratory rate

    Change from pre-dose to 24 h in respiratory rate (breaths per minute)

    Time frame: 0-24 hours

  24. Body Temperature

    Change from pre-dose to 24 h in body temperature (°C)

    Time frame: 0-24 hours

  25. Composite Measure of Physical Abnormalities Observed in A Comprehensive Physical Exam

    Presence or absence of physical abnormalities in general appearance

    Time frame: 12 hours

  26. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of ears

    Time frame: 12 hours

  27. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of eyes

    Time frame: 12 hours

  28. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of nose

    Time frame: 12 hours

  29. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of throat

    Time frame: 12 hours

  30. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of skin

    Time frame: 12 hours

  31. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of chest

    Time frame: 12 hours

  32. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of lungs

    Time frame: 12 hours

  33. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of abdomen

    Time frame: 12 hours

  34. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of physical abnormalities of lymph nodes

    Time frame: 12 hours

  35. Composite Measure of Physical Abnormalities Observed in a Comprehensive Physical Exam

    Presence or absence of neurological abnormalities

    Time frame: 12 hours

  36. Incidence of Adverse Events

    Number of participants with adverse events

    Time frame: minimum of 14 days, maximum of 28 days

  37. Whole Blood Hemoglobin

    Change from pre-dose in whole blood hemoglobin (g/dL)

    Time frame: 12 hours

  38. Whole Blood Hematocrit

    Change from pre-dose in whole blood hematocrit (%)

    Time frame: 12 hours

  39. Whole Blood White Blood Cells

    Change from pre-dose in whole blood white blood cells (x10\^3/uL)

    Time frame: 12 hours

  40. Whole Blood Neutrophils

    Change from pre-dose in whole blood neutrophils (cells/uL)

    Time frame: 12 hours

  41. Whole Blood Eosinophils

    Change from pre-dose in whole blood eosinophils (cells/uL)

    Time frame: 12 hours

  42. Whole Blood Basophils

    Change from pre-dose in whole blood basophils (cells/uL)

    Time frame: 12 hours

  43. Whole Blood Lymphocytes

    Change from pre-dose in whole blood lymphocytes (cells/uL)

    Time frame: 12 hours

  44. Whole Blood Monocytes

    Change from pre-dose in whole blood monocytes (cells/uL)

    Time frame: 12 hours

  45. Whole Blood Mean Platelet Volume

    Change from pre-dose in whole blood mean platelet volume (fL)

    Time frame: 12 hours

  46. Whole Blood Platelet Count

    Change from pre-dose in whole blood platelet count (x10\^9/L)

    Time frame: 12 hours

  47. Whole Blood Red Blood Cell Count

    Change from pre-dose in whole blood red blood cell count (x10\^6/uL)

    Time frame: 12 hours

  48. Whole Blood Red Blood Cell Distribution Width

    Change from pre-dose in whole blood red blood cell distribution width (%)

    Time frame: 12 hours

  49. Whole Blood Mean Corpuscular Volume

    Change from pre-dose in whole blood mean corpuscular volume (fL)

    Time frame: 12 hours

  50. Whole Blood Mean Corpuscular Hemoglobin

    Change from pre-dose in whole blood mean corpuscular hemoglobin (pg)

    Time frame: 12 hours

  51. Whole Blood Mean Corpuscular Hemoglobin Concentration

    Change from pre-dose in whole blood mean corpuscular hemoglobin concentration (g/dL)

    Time frame: 12 hours

  52. Serum Sodium

    Change from pre-dose in serum sodium (mmol/L)

    Time frame: 12 hours

  53. Serum Potassium

    Change from pre-dose in serum potassium (mmol/L)

    Time frame: 12 hours

  54. Serum Chloride

    Change from pre-dose in serum chloride (mmol/L)

    Time frame: 12 hours

  55. Serum Urea

    Change from pre-dose in serum urea (mg/dL)

    Time frame: 12 hours

  56. Serum Creatinine

    Change from pre-dose in serum creatinine (umol/L)

    Time frame: 12 hours

  57. Serum Estimated Glomerular Filtration

    Change from pre-dose in serum estimated glomerular filtration rate (mL/min/1.73\^2)

    Time frame: 12 hours

  58. Serum Total Protein

    Change from pre-dose in serum total protein (g/dL)

    Time frame: 12 hours

  59. Serum Albumin

    Change from pre-dose in serum albumin (g/dL)

    Time frame: 12 hours

  60. Serum Globulin

    Change from pre-dose in serum globulin (g/dL)

    Time frame: 12 hours

  61. Serum Total Bilirubin

    Change from pre-dose in serum total bilirubin (mg/dL)

    Time frame: 12 hours

  62. Serum Glucose

    Change from pre-dose in serum glucose concentration (mg/dL)

    Time frame: 12 hours

  63. Serum Alanine Transaminase

    Change from pre-dose in serum alanine transaminase concentration (U/L)

    Time frame: 12 hours

  64. Serum Aspartate Transaminase

    Change from pre-dose in serum aspartate transaminase concentration (U/L)

    Time frame: 12 hours

  65. Serum Alkaline Phosphatase

    Change from pre-dose in serum alkaline phosphatase concentration (U/L)

    Time frame: 12 hours

  66. Gamma Glutamyl Transferase

    Change from pre-dose in serum gamma glutamyl transferase concentration (U/L)

    Time frame: 12 hours

07

Study locations

1 site
  • Nutrasource Site (Apex Trials)
    Guelph, Ontario N1G0B4, Canada
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06578455
Lead sponsor
DSM Nutritional Products, Inc.
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Aug 30, 2024
Primary completion
Nov 20, 2024
Completion
Dec 16, 2024
Last update
Dec 17, 2024

Study contacts

Anthony Bier, MD
principal investigator · Apex Trials

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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