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A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05121506
Recruitment Status : Completed
First Posted : November 16, 2021
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Gefion Canada Inc.

Brief Summary:
The bioavailability of cannabinoids differs greatly for different routes of administration. When applied topically to the skin, they are absorbed through the skin or hair follicles while interacting with receptors to provide localized effects. To gain more information on the potential of this route of administration in therapeutic applications, this open-label study will investigate the skin absorption and bioavailability of CBD and THC delivered trans-dermally.

Condition or disease Intervention/treatment Phase
Biological Availability Skin Absorption CBD THC Combination Product: CBD and THC with GT4 technology Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-arm Open-label Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults
Actual Study Start Date : November 27, 2021
Actual Primary Completion Date : January 18, 2022
Actual Study Completion Date : January 18, 2022

Arm Intervention/treatment
Experimental: CBD and THC with GT4 technology Combination Product: CBD and THC with GT4 technology
A single topical dose of CBD and THC will be administered with GT4 technology. The material will be provided in a single use pre-filled syringe.




Primary Outcome Measures :
  1. Area under the curve to the last measured timepoint (AUCT) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The AUCT will be calculated using the trapezoid approximation. Time points assessed for AUC0-12 h: pre-dose (T = 0 h) and post-dose at 10, 20, 30, 45 min and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 h.

  2. Area under the curve to the last measured timepoint (AUCT) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The AUCT will be calculated using the trapezoid approximation. Time points assessed for AUC0-12 h: pre-dose (T = 0 h) and post-dose at 10, 20, 30, 45 min and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 h. This parameter will be presented for each metabolite, for each study participant.

  3. Maximum concentration (Cmax) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Peak concentration (Cmax) will be determined directly from the concentration-time curve.

  4. Maximum concentration (Cmax) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Peak concentration (Cmax) will be determined directly from the concentration-time curve.

  5. Time to maximum concentration (Tmax) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Time to peak concentration (Tmax) will be determined directly from the concentration-time curve.

  6. Time to maximum concentration (Tmax) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Time to peak concentration (Tmax) will be determined directly from the concentration-time curve.

  7. Area under the curve to infinity (AUCI) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The area under the curve to infinity AUCI will be calculated by AUCT + CT/ λ, where CT is the last quantifiable concentration.

  8. Area under the curve to infinity (AUCI) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The area under the curve to infinity AUCI will be calculated by AUCT + CT/ λ, where CT is the last quantifiable concentration.

  9. Terminal elimination rate constant (λ or ke) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal disposition rate constant (λ) will be calculated as the slope of points on the terminal log-linear end of the concentration versus time curve.

  10. Terminal elimination rate constant (λ or ke) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal disposition rate constant (λ) will be calculated as the slope of points on the terminal log-linear end of the concentration versus time curve.

  11. Terminal half-life (t1/2) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal half-life (t1/2) will be calculated as ln(2)/λ = 0.693/λ.

  12. Terminal half-life (t1/2) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal half-life (t1/2) will be calculated as ln(2)/λ = 0.693/λ.

  13. Absorption rate constant (ka) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The absorption rate constant (ka) will be calculated using the feathering method.

  14. Absorption rate constant (ka) for THC metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The absorption rate constant (ka) will be calculated using the feathering method.


Other Outcome Measures:
  1. Incidence of pre-emergent and post-emergent adverse events (AEs) following a single dose of CBD and THC from GT4 technology [ Time Frame: 12-hour study period and follow-up call at 7 days ]
    Number of pre-emergent and post-emergent adverse events will be determined to calculate the incidence. Adverse events will be recorded during the 12 h in-clinic visit and during a follow-up phone call (7 days)

  2. Change in Aspartate Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in Aspartate Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  3. Change in Alanine Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in Alanine Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  4. Change in Alkaline Phosphatase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline [ Time Frame: 12-hour study period ]
    Change in Alkaline Phosphatase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  5. Change in Total Bilirubin at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in Total Bilirubin at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  6. Change in Creatinine at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in Creatinine at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  7. Change in Estimated Glomerular Filtration Rate (eGFR) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in eGFR at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  8. Change in random glucose at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in random glucose at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  9. Change in sodium levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in sodium levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  10. Change in potassium levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in potassium levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  11. Change in chloride levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in chloride levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  12. Change in White Blood Cell Count (WBC) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in WBC at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  13. Change in amount of Neutrophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in amount of Neutrophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  14. Change in amount of Lymphocytes at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in amount of Lymphocytes at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  15. Change in amount of Monocytes at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in amount of Monocytes at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  16. Change in amount of Eosinophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in amount of Eosinophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  17. Change in amount of Basophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in amount of Basophils at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  18. Change in Red Blood Cell Count (RBC) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in Red Blood Cell Count (RBC) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  19. Change in hemoglobin levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in hemoglobin levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  20. Change in hematocrit levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in hematocrit levels at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  21. Change in platelet count at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in platelet count at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  22. Change in Mean Corpuscular Volume (MCV) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in MCV at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  23. Change in mean corpuscular hemoglobin (MCH) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in MCH at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  24. Change in mean corpuscular hemoglobin concentration (MCHC) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in MCHC at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  25. Change in red cell distribution width (RDW) at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline. [ Time Frame: 12-hour study period ]
    Change in RDW at 12-h post dose following acute topical administration using GT4 technology of CBD and THC will be compared to baseline.

  26. Psychoactive Assessment following acute topical administration using GT4 technology of CBD and THC. [ Time Frame: 12-hour study period ]

    Psychoactive Assessment as administered at post-dose at 10, 20, 30, 45 min and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 h.

    The "Psychoactive Assessment" will be administered just before each post-dose blood draw with the following questions:

    1. Are you experiencing a "high" feeling?
    2. On a scale of 1 (least) to 10 (most), how intense is that feeling?
    3. Is this "high" feeling (other than intensity) different than past high experiences? If yes, please describe.

  27. Area under the curve to the last measured timepoint (AUCT) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The AUCT will be calculated using the trapezoid approximation. Time points assessed for AUC0-12 h: pre-dose (T = 0 h) and post-dose at 10, 20, 30, 45 min and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 h.

  28. Maximum concentration (Cmax) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Peak concentration (Cmax) will be determined directly from the concentration-time curve.

  29. Time to maximum concentration (Tmax) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Time to peak concentration (Tmax) will be determined directly from the concentration-time curve.

  30. Area under the curve to infinity (AUCI) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The area under the curve to infinity AUCI will be calculated by AUCT + CT/ λ, where CT is the last quantifiable concentration.

  31. Terminal elimination rate constant (λ or ke) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal disposition rate constant (λ) will be calculated as the slope of points on the terminal log-linear end of the concentration versus time curve.

  32. Terminal half-life (t1/2) for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    Terminal half-life (t1/2) will be calculated as ln(2)/λ = 0.693/λ.

  33. Absorption rate constant (ka) for for Cannabinol (CBN) metabolite following acute topical administration using GT4 technology of CBD and THC [ Time Frame: 12-hour study period ]
    The absorption rate constant (ka) will be calculated using the feathering method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and females between 25-65 years of age at screening
  2. Body Mass Index (BMI) from 18.5 to 29.9 kg/m2, inclusive
  3. Occasional users of cannabis: Have consumed cannabis products at least once in the past 6 months and at least 4 times in their lifetime but no more than 3 times per week and not within 48 hours of Visit 2 and have experienced psychotropic effects without severe adverse events (short term paranoia, belligerence, extreme hallucinations) requiring medical interventions. Eligibility will be determined on a case by case basis by the QI
  4. Female participant is not of child bearing potential, which is defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have undergone natural menopause (have not had menses for > 1 year) OR

    Females of childbearing potential must agree to abstain from heterosexual intercourse or use two methods of contraception for 30 days prior to first treatment and for 30 days after the treatment. Subjects must have a negative urine pregnancy test result at screening and baseline. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    2. Double-barrier method
    3. Intrauterine devices
    4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    5. Vasectomy of partner at least 6- months prior to screening
  5. A male participant with sexual partners who are not pregnant or do not fit the criteria as indicated above in number 4 must meet the following criteria

    • Participant is unlikely to procreate, defined as surgically sterile (i.e. has undergone vasectomy, it must be at least 6 months since the surgery)
    • Participant agrees to use of the accepted contraceptive regimens from first drug administration until 30 days after the drug administration
    • An acceptable method of contraception includes one of the following:

      • Abstinence from heterosexual intercourse
      • Condom with spermicide
  6. Agrees to avoid alcohol intake 48 h prior to visit 2
  7. Agrees to avoid tobacco or nicotine-containing products 96 hours prior to visit 2
  8. Healthy as determined by medical history and laboratory results, as assessed by the QI
  9. Agrees to complete all study related procedures and assessments
  10. Agrees to provide information of two adult contacts to be reached in the event of transportation requirements from the clinic to their home after the study visits
  11. Provides voluntary, written informed consent to participate in the study

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
  2. Allergy or sensitivity to investigational product's active or inactive ingredients
  3. Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological conditions (open wounds, scars, sunburns, moles) in the proposed area of application that would interfere with the application and absorption of the test product
  4. Shaving, waxing or laser hair removal of the planned study treatment application area within 14 days prior to baseline. Tattoos on the planned study application area.
  5. Current use of prescribed medication containing the ingredients in the IP
  6. Current use of over-the-counter medications, supplements, and foods/drinks containing the ingredients in the IP unless willing to washout
  7. Prescribed or OTC medication, supplements, or food/drinks that will interact with the investigational product
  8. Positive drug of abuse test at baseline
  9. History of alcohol and/or drug abuse or substance dependence within the last 12 months
  10. High alcohol intake (average of >2 standard drinks per day)
  11. Self-reported serious psychological disorder(s) diagnosis e.g. schizophrenia, bipolar disorder, depression, PTSD, sleep disorder that, in the QI's opinion, could interfere with study participation. History of suicidal ideation, attempts and/or behaviour.
  12. History of psychosis in immediate family including schizophrenia and affective psychosis
  13. Cancer, except basal cell skin carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
  15. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  16. Self-reported cardiovascular disease. Participants with no significant cardiovascular event in the past 1 year and who are on stable medication may be included after assessment by the QI on a case-by-case basis
  17. Individuals with an autoimmune disease or who are immune-compromised
  18. Positive laboratory results for HIV, Hepatitis B or C as assessed at screening
  19. Type I or Type II diabetes
  20. Current or history of significant liver disease or dysfunction that in the opinion of the QI may impact study outcomes or participant safety
  21. History of or current diagnosis with kidney diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
  22. Self-reported current or pre-existing thyroid condition. Treatment on a stable dose medication for over 6 months will be reviewed on a case-by-case basis by the QI
  23. Self- reported blood/bleeding disorder as assessed by the QI
  24. Clinically significant abnormal laboratory results at screening as determined by the QI
  25. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
  26. Participation in other clinical research trials 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
  27. Individuals who are unable to give informed consent
  28. Any other condition or lifestyle factor, that, in the opinion of the QI may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121506


Locations
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Canada, Ontario
KGK Science Inc.
London, Ontario, Canada
Sponsors and Collaborators
Gefion Canada Inc.
KGK Science Inc.
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.
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Responsible Party: Gefion Canada Inc.
ClinicalTrials.gov Identifier: NCT05121506    
Other Study ID Numbers: 19GBHG
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gefion Canada Inc.:
CBD
THC
GT4 Technology