A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population

NCT04601207 | Completed Phase 1

• 1 other identifier: 18CBHN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the bioavailability of Cannabidiol (CBD) and Tetrahydrocannabinol (THC) in an emulsion product against a comparator product. Thirty-two participants will be randomized into a single-center, double-blind, parallel trial. Participants will be dosed in clinic and blood and urine samples will be taken over a 12-hour period. Blood and urine samples will also be collected for 48 hours post-dose at check-in visits. Questionnaires regarding drug effects and cognitive function will also be completed following each blood sampling. Participants who consumed the comparator product will be asked to return to the clinic following a wash-out period of at least 45 days to consume the emulsion product in-clinic and complete questionnaires at the same specified time points over a 12-hour period.

Conditions

Healthy; Cannabis

Keywords

Cannabis; THC; CBD; Healthy Adult

Outcome Measures

Primary Outcomes (3)

• Area under the curve (AUC0-48h)

  Area under the curve (AUC0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product.

  48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours)

• Maximum concentration (Cmax, 0-48h)

  Maximum concentration (Cmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product.

  48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours)

• Time to maximum concentration (Tmax)

  Time to maximum concentration (Tmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product.

  48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours)

Secondary Outcomes (4)

• Urine CBD concentration

  48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose)

• Urine Δ9-THC concentration

  48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose)

• Cognitive function

  48 hours

• Subjective evaluation of drug effects

  48 hours

Other Outcomes (26)

• Pre-emergent and post-emergent adverse events

  72 hours

• Blood pressure

  48 hours post dose

• Heart rate

  48 hours post dose

Study Arms (2)

Solutech™- TC10

EXPERIMENTAL

10.0mg THC, 12.2 mg CBD liquid emulsion product given orally once in-clinic

Drug: Cannabis Preparation

MCT-diluted Cannabis Product

ACTIVE COMPARATOR

10.0mg THC, 12.2 mg CBD liquid MCT-diluted oil product given orally once in-clinic

Drug: Cannabis Preparation

Interventions

Cannabis Preparation DRUG

Dosed as a single oral dose

Also known as: Cannabis emulsion

Solutech™- TC10

Eligibility Criteria

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

You may qualify if:

• Provide voluntary, written informed consent to participate in the study
• Between 18 and 45 years of age at screening
• Occasional users of Cannabis: Have consumed cannabis product at least once in the past 6 months and at least 4 times in their lifetime 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.
• Must agree to a 30-day washout of cannabis products prior to baseline.
• Willingness to complete questionnaires, records and diaries associated with the study
• Have a Body Mass Index (BMI) in the range of 19.0 to 29.9 kg/m2 at baseline
• Be willing to provide blood over a 12 h period via an Intravenous (IV) catheter
• Blood pressure at screening does not exceed a systolic blood pressure (SBP) of 140 mmHg and a diastolic blood pressure (DBP) of 90 mmHg
• Agree to refrain from smoking tobacco products, including e-cigarettes and vaporizers or consume alcohol 24 hrs prior to their baseline visit and until completion of the study period.
• Men who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the end of the study and report any pregnancies. If a subject's partner becomes pregnant during his participation in the study or within 30 days after he has completed his last drug administration, he must inform the QI immediately
• Female participant is not of child bearing potential, which is defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation or natural menopause (have not had menses for \> 1 year, as confirmed by measurement of serum FSH ≥ 40 IU/L at screening visit) 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 last treatment. Subjects must have a negative urine pregnancy test result at screening, baseline and visit 5. 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

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• Clinically significant abnormal laboratory results at screening as determined by the QI.
• Verbal confirmation of hepatic or pancreatic malfunctions
• Verbal confirmation of use of medicinal or recreational products containing CBD/THC in the past 1 month, for participants that have consumed CBD or THC containing products prior to 1 month, eligibility will be assessed by the QI on a case by case basis depending on frequency and amount.
• Verbal confirmation of use of hemp seeds or hemp oil in the past 1 month, for participants that have consumed hemp seeds or hemp oil prior to 1 month, eligibility will be assessed by the QI on a case by case basis depending on frequency and amount.
• Verbal confirmation of habitual use of cannabis for medical or recreational purposes: \>4 times a month. For participants who have consumed cannabis products ≤4 times a month, eligibility will be assessed by the QI depending on dose and frequency of use and self reported adverse events
• Tongue piercings and/or mouth jewelry
• Cancer, except skin cancers 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 after an assessment by QI
• History (within the past 5 years) of or current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis of substance dependence. For participants who have a history of substance dependence greater than 5 years ago, eligibility will be assessed on a case by case basis by the QI.
• Currently seeking or participating in treatment for substance-related disorders
• History of participation in treatment for substance-related disorders, including successful completion of such treatment within the past 5 years. For participants who have a sought treatment for substance abuse greater than 5 years ago, eligibility will be assessed on a case by case basis by the QI.
• Clinically significant history of or presence of any clinically significant oral or gastrointestinal pathology (e.g. mouth ulcers, chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to baseline (visit 2) and visit 5.
• Use of prescribed or over the counter medication which in the opinion of QI will interfere with study results or safety of the subject. Please refer to Section 5.3.1 and 5.3.2.
• Verbal confirmation of current or history of bleeding disorders. Will be assessed by QI on a case by case basis depending on the disorder
• Participation in a clinical research trial within 30 days prior to randomization

Sponsors & Collaborators

• New Age Ventures LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 35787693 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, comparator-controlled

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: October 23, 2020
• Study Start: June 19, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

CA (1)