Study of Cannabidiol (CBD) in Healthy Volunteers

NCT06286839 | Completed

• 1 other identifier: AFCRO-150
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults

Conditions

Immune System and Related Disorders; Immune System Diseases

Keywords

CBD; Phase 1; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days

  Difference in plasma CBD concentration (ng/ml) between groups as measured by total Area Under the Curve (tAUC) derived from plasma

  T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)

• Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)

Secondary Outcomes (3)

• Plasma CBD maximal concentration (Cmax, ng/ml)

  T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)

• Plasma CBD time to peak (Tmax, minutes)

  T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)

• Percentage Change between groups on whole blood LPS stimulated cytokines (% change)

  T0 minutes, T4320 minutes(72 Hours)

Study Arms (2)

30 mg twice per day

EXPERIMENTAL

The 30mg dose will be consumed in 2 capsules twice per day, for 3 days and an extra 18 capsules in case of loss of study product

Dietary Supplement: Cannabidiol (CBD)

120 mg twice per day

EXPERIMENTAL

120mg dose will be consumed in 8 capsules twice per day for 3 days and an extra 12 capsules in case of loss of study product

Dietary Supplement: Cannabidiol (CBD)

Interventions

Cannabidiol (CBD) DIETARY_SUPPLEMENT

Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L.

120 mg twice per day; 30 mg twice per day

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 18 and 45, inclusive.
• Has a BMI between 18-29.50 kg/m2.
• Is in general good health, as determined by the investigator.
• Willing to abstain from consuming tobacco or nicotine- containing products, consuming alcohol, grapefruit, or grapefruit juice, or taking any prescription drugs, dietary supplements, or non-prescription drugs for the periods required by the study protocol.
• Willing to consume the investigational product daily for the duration of the trial.
• Willing and able to communicate effectively with the study personnel and willing to comply with all protocol requirements, including visit schedule and oral intake of investigational product
• Willing to consume the standard meal and an 8oz Boost nutritional drink at visit 2

You may not qualify if:

• Are less than 18 or greater than 45
• Participants who are pregnant or wish to become pregnant during the trial.
• Participants who are lactating and/or currently breastfeeding
• Post-menopausal, defined as one year without menses.
• Participants currently of childbearing potential but not using an effective method of contraception, as outlined below:
• Complete abstinence from intercourse two weeks before administration of the investigational product, throughout the clinical trial, until the completion of follow-up procedures, or for two weeks following discontinuation of the investigational product in cases where the participant discontinues the trial prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
• Has a male sexual partner who is surgically sterilized before the Screening Visit and is the only male sexual partner for that participant.
• Sexual partner(s) is/are exclusively female.
• Use of an acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), or contraceptive pill.
• The participant must use this method for at least 1 week before and 1 week following the end of the trial.
• Use of any intrauterine device (IUD) or contraceptive implant. The participant must have the device inserted at least 2 weeks before the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
• Are hypersensitive to any of the components of the investigational product.
• Has taken any dietary supplement or non-prescription drugs within 3 days prior to baseline or has taken any prescription drugs within 14 days prior to baseline (antihistamines, acetaminophen, contraception or single- use over-the-counter medications including nonsteroidal anti-inflammatory drugs (NSAIDs) allowed before baseline.
• Has a self-reported history of drug and/or alcohol abuse at the time of within 6 months before screening or exhibits evidence of drug and/or alcohol abuse at baseline.
• Has consumed alcohol within 24 hours before screening and baseline.

Sponsors & Collaborators

• NextEvo Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Altantia Clinical Trials

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• Millar SA, Stone NL, Yates AS, O'Sullivan SE. A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Front Pharmacol. 2018 Nov 26;9:1365. doi: 10.3389/fphar.2018.01365. eCollection 2018.

  PMID: 30534073 BACKGROUND

• Brunet LR, LaBrie S, Hagemann T. Immune monitoring technology primer: immunoprofiling of antigen-stimulated blood. J Immunother Cancer. 2016 Mar 15;4:18. doi: 10.1186/s40425-016-0122-4. eCollection 2016. No abstract available.

  PMID: 26981248 BACKGROUND

• Hobbs JM, Vazquez AR, Remijan ND, Trotter RE, McMillan TV, Freedman KE, Wei Y, Woelfel KA, Arnold OR, Wolfe LM, Johnson SA, Weir TL. Evaluation of pharmacokinetics and acute anti-inflammatory potential of two oral cannabidiol preparations in healthy adults. Phytother Res. 2020 Jul;34(7):1696-1703. doi: 10.1002/ptr.6651. Epub 2020 Mar 8.

  PMID: 32147925 BACKGROUND

• Williams NNB, Ewell TR, Abbotts KSS, Harms KJ, Woelfel KA, Dooley GP, Weir TL, Bell C. Comparison of Five Oral Cannabidiol Preparations in Adult Humans: Pharmacokinetics, Body Composition, and Heart Rate Variability. Pharmaceuticals (Basel). 2021 Jan 6;14(1):35. doi: 10.3390/ph14010035.

  PMID: 33418866 BACKGROUND

MeSH Terms

Conditions

Immune System Diseases

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Alice Eggleston

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

• David Chernoff, MD

  NextEvo Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: February 29, 2024
• Study Start: May 12, 2022
• Primary Completion: October 28, 2022
• Study Completion: December 14, 2022
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)