Immune System and Related DisordersNCT06286839
Study of Cannabidiol (CBD) in Healthy Volunteers
A study testing Cannabidiol (CBD) in people with Immune System and Related Disorders and Immune System Diseases, run by NextEvo Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System and Related Disorders, Immune System Diseases
- What is being tested?
- Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 14 Dec 2022
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
- Has consumed grapefruit or grapefruit juice within 3 days before screening or baseline
- The participant has a current acute or chronic disease, which may, in the opinion of the investigator, impact the outcomes of the study.
- The participant has clinically significant abnormal findings outside the normal screening ranges.
- The participant has clinically significant abnormal findings from physical examination at screening and baseline that may, in the investigator's opinion, impact the study's outcomes.
- The participant has a clinically important history of a medical disorder that may, in the opinion of the investigator, compromise the participant's safety or data quality
- Current regular tobacco vape or nicotine-containing product use within 60 days prior to screening and between screening and baseline (Occasional use defined as less than 5 cigarettes per week or equivalent nicotine product/vape use)
- Use of tetrahydrocannabinol (THC)/cannabidiol (CBD) products in within 7 days of screening.
- The participant has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important reaction to any drug which, in the opinion of the investigator, impacts the outcomes of the study.
- A history of human immunodeficiency virus infection/acquired immune deficiency syndrome or a positive screening assessment for human immunodeficiency virus or viral hepatitis.
- Evidence of amphetamines, barbiturates, Benzodiazepine (including prescription), cannabinoids, cocaine, opiates, phencyclidine, or ethanol on a urine drug screening at screening.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- Participants may not be receiving treatment involving experimental drugs or devices. If the participant has been in a recent experimental trial, these must have been completed at least 30 prior to this trial.
- Any Participant who is an employee of the investigational site an Atlantia Clinical Trials employee or their close family member, or a member of their household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Parallel Phase I Study Evaluating Multiple Ascending Dose Pharmacokinetics and Acute Immunomodulatory Potential of a Novel Oral Cannabidiol (CBD) Formulation
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
Read the detailed description
Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L., has been purported to have a variety of beneficial physiological effects including but not limited to, pain relief, anti-anxiety, anti-seizure, anti-depressant, anti-oxidant, and anti-inflammatory. Despite the enthusiasm of the CBD industry for these claims, the empirical evidence supporting favourable physiological responses is inconsistent. These discrepancies may in part be explained by differences in CBD bioavailability when administered orally that in turn may be influenced by non-standardized CBD formulation, and/or the body size and composition of the recipient.
The purpose of this study was to test the bioavailability of two doses of a novel CBD formation given twice per day for three consecutive days in healthy study subjects and explore their potential acute anti-inflammatory properties as assessed by highly sensitive immunologic assays. The rationale for conducting the study was to evaluate the pharmacokinetic (PK) profile of a novel formulation of CBD designed to improve bioavailability given at two dose levels twice per day for three consecutive days. Although previous studies conducted in healthy study subjects have documented the safety and PK profile for a single dose of the test product, multiple ascending dose studies have not yet been conducted. In addition to evaluating multiple ascending dose PK, the pharmacodynamic properties of the CBD were assessed using ex vivo lipopolysaccharides (LPS) stimulated whole blood assays and high sensitivity serum cytokine assays.
- Being tested
- Cannabidiol (CBD)
- Keywords
- CBD, Phase 1, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Dietary supplement
Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Difference in plasma Cmax concentration between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Measured: 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)
Difference in plasma Tmax concentration between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Measured: 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)
Differences between groups for the change from baseline were assessed for whole blood LPS stimulated cytokines
Measured: T0 minutes, T4320 minutes(72 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start12 May 2022
- Primary completion28 Oct 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immune System and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextEvo Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Alice Eggleston, Principal investigator, Atlantia Clinical TrialsDavid Chernoff, MD, Study director, NextEvo Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286839
- Sponsor's protocol ID
- AFCRO-150
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data in this study will be published by NextEvo
Publications
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.
PubMed 30534073Brunet 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.
PubMed 26981248Hobbs 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.
PubMed 32147925Williams 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.
PubMed 33418866
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Parallel Phase I Study Evaluating Multiple Ascending Dose Pharmacokinetics and Acute Immunomodulatory Potential of a Novel Oral Cannabidiol (CBD) Formulation
- ClinicalTrials.gov ID
- NCT06286839
- Acronym / sponsor ID
- AFCRO-150
- Keywords
- CBD, Phase 1, Pharmacokinetics, Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NextEvo Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 12 May 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L., has been purported to have a variety of beneficial physiological effects including but not limited to, pain relief, anti-anxiety, anti-seizure, anti-depressant, anti-oxidant, and anti-inflammatory. Despite the enthusiasm of the CBD industry for these claims, the empirical evidence supporting favourable physiological responses is inconsistent. These discrepancies may in part be explained by differences in CBD bioavailability when administered orally that in turn may be influenced by non-standardized CBD formulation, and/or the body size and composition of the recipient.
The purpose of this study was to test the bioavailability of two doses of a novel CBD formation given twice per day for three consecutive days in healthy study subjects and explore their potential acute anti-inflammatory properties as assessed by highly sensitive immunologic assays. The rationale for conducting the study was to evaluate the pharmacokinetic (PK) profile of a novel formulation of CBD designed to improve bioavailability given at two dose levels twice per day for three consecutive days. Although previous studies conducted in healthy study subjects have documented the safety and PK profile for a single dose of the test product, multiple ascending dose studies have not yet been conducted. In addition to evaluating multiple ascending dose PK, the pharmacodynamic properties of the CBD were assessed using ex vivo lipopolysaccharides (LPS) stimulated whole blood assays and high sensitivity serum cytokine assays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 mg twice per day | Experimental | Dietary Supplement: Cannabidiol (CBD)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 |
| 120 mg twice per day | Experimental | Dietary Supplement: Cannabidiol (CBD)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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L. | Dietary supplement | 120 mg twice per day, 30 mg twice per day |
Primary outcome
Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Difference in plasma CBD concentration (ng/ml) between groups as measured by total Area Under the Curve (tAUC) derived from plasma
Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days
Time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 Hours)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 secondary outcomes
Plasma CBD maximal concentration (Cmax, ng/ml)
Time frame: 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)
Time frame: 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)
Time frame: T0 minutes, T4320 minutes(72 Hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 30534073Millar 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.
- Background: PubMed 26981248Brunet 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.
- Background: PubMed 32147925Hobbs 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.
- Background: PubMed 33418866Williams 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.
- Individual participant dataSharing planned: No. The data in this study will be published by NextEvo
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Eggleston principal investigator
Atlantia Clinical Trials
David Chernoff, MD study director
NextEvo Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol (CBD) in people with Immune System and Related Disorders and Immune System Diseases, run by NextEvo Inc. at 1 site in United States.
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 8 inclusion and 28 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 29 Feb 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 United States. 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.
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?
Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days (time frame: T-30 minutes, T 0 minutes, T30 minutes, T60 minutes, T240 minutes (4 Hours), T480 minutes (8 Hours), and T4320 minutes (72 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 NCT06286839, which also lists 4 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 29 Feb 2024.