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

NCT05121506 | Completed Phase 1

• 1 other identifier: 19GBHG
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Biological Availability; Skin Absorption; CBD; THC

Keywords

CBD; THC; GT4 Technology

Outcome Measures

Primary Outcomes (14)

• Area under the curve to the last measured timepoint (AUCT) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  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.

  12-hour study period

• Area under the curve to the last measured timepoint (AUCT) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  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.

  12-hour study period

• Maximum concentration (Cmax) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  Peak concentration (Cmax) will be determined directly from the concentration-time curve.

  12-hour study period

• Maximum concentration (Cmax) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  Peak concentration (Cmax) will be determined directly from the concentration-time curve.

  12-hour study period

• Time to maximum concentration (Tmax) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  Time to peak concentration (Tmax) will be determined directly from the concentration-time curve.

  12-hour study period

• Time to maximum concentration (Tmax) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  Time to peak concentration (Tmax) will be determined directly from the concentration-time curve.

  12-hour study period

• Area under the curve to infinity (AUCI) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  The area under the curve to infinity AUCI will be calculated by AUCT + CT/ λ, where CT is the last quantifiable concentration.

  12-hour study period

• Area under the curve to infinity (AUCI) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  The area under the curve to infinity AUCI will be calculated by AUCT + CT/ λ, where CT is the last quantifiable concentration.

  12-hour study period

• Terminal elimination rate constant (λ or ke) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  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.

  12-hour study period

• Terminal elimination rate constant (λ or ke) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  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.

  12-hour study period

• Terminal half-life (t1/2) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  Terminal half-life (t1/2) will be calculated as ln(2)/λ = 0.693/λ.

  12-hour study period

• Terminal half-life (t1/2) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  Terminal half-life (t1/2) will be calculated as ln(2)/λ = 0.693/λ.

  12-hour study period

• Absorption rate constant (ka) for CBD metabolite following acute topical administration using GT4 technology of CBD and THC

  The absorption rate constant (ka) will be calculated using the feathering method.

  12-hour study period

• Absorption rate constant (ka) for THC metabolite following acute topical administration using GT4 technology of CBD and THC

  The absorption rate constant (ka) will be calculated using the feathering method.

  12-hour study period

Other Outcomes (33)

• Incidence of pre-emergent and post-emergent adverse events (AEs) following a single dose of CBD and THC from GT4 technology

  12-hour study period and follow-up call at 7 days

• Change in Aspartate Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline.

  12-hour study period

• Change in Alanine Aminotransferase at 12-h post dose following acute topical administration using GT4 technology of CBD and THC compared to baseline.

  12-hour study period

Study Arms (1)

CBD and THC with GT4 technology

EXPERIMENTAL

Combination Product: CBD and THC with GT4 technology

Interventions

CBD and THC with GT4 technology COMBINATION_PRODUCT

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.

CBD and THC with GT4 technology

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females between 25-65 years of age at screening
• Body Mass Index (BMI) from 18.5 to 29.9 kg/m2, inclusive
• 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
• 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:
• 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)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6- months prior to screening
• 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

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
• Allergy or sensitivity to investigational product's active or inactive ingredients
• 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
• 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.
• Current use of prescribed medication containing the ingredients in the IP
• Current use of over-the-counter medications, supplements, and foods/drinks containing the ingredients in the IP unless willing to washout
• Prescribed or OTC medication, supplements, or food/drinks that will interact with the investigational product
• Positive drug of abuse test at baseline
• History of alcohol and/or drug abuse or substance dependence within the last 12 months
• High alcohol intake (average of \>2 standard drinks per day)
• 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.
• History of psychosis in immediate family including schizophrenia and affective psychosis
• 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
• 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
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI

Sponsors & Collaborators

• Gefion Canada Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, Canada

Location

Related Publications (1)

• Varadi G, Zhu Z, Crowley HD, Moulin M, Dey R, Lewis ED, Evans M. Examining the Systemic Bioavailability of Cannabidiol and Tetrahydrocannabinol from a Novel Transdermal Delivery System in Healthy Adults: A Single-Arm, Open-Label, Exploratory Study. Adv Ther. 2023 Jan;40(1):282-293. doi: 10.1007/s12325-022-02345-5. Epub 2022 Oct 29.

  PMID: 36308640 DERIVED

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 27, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CA (1)