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Trial record 85 of 808 for:    Area Under Curve AND Bioavailability

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

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ClinicalTrials.gov Identifier: NCT04601207
Recruitment Status : Completed
First Posted : October 23, 2020
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
New Age Ventures LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Cannabis Drug: Cannabis Preparation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, comparator-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Single-center, Randomized, Double-blind, Comparator-controlled Parallel Study Investigating the Bioavailability of Cannabidiol and Δ9-Tetrahydrocannabinol in an Emulsion Product in a Healthy Population
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Solutech™- TC10
10.0mg THC, 12.2 mg CBD liquid emulsion product given orally once in-clinic
Drug: Cannabis Preparation
Dosed as a single oral dose
Other Name: Cannabis emulsion

Active Comparator: MCT-diluted Cannabis Product
10.0mg THC, 12.2 mg CBD liquid MCT-diluted oil product given orally once in-clinic
Drug: Cannabis Preparation
Dosed as a single oral dose
Other Name: Cannabis oil




Primary Outcome Measures :
  1. Area under the curve (AUC0-48h) [ Time Frame: 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) ]
    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.

  2. Maximum concentration (Cmax, 0-48h) [ Time Frame: 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) 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.

  3. Time to maximum concentration (Tmax) [ Time Frame: 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, 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.


Secondary Outcome Measures :
  1. Urine CBD concentration [ Time Frame: 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) ]
    CBD concentrations in urine after the acute administration of the investigational product and the active comparator product

  2. Urine Δ9-THC concentration [ Time Frame: 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) ]
    Δ9-THC concentrations in urine after the acute administration of the investigational product and the active comparator product

  3. Cognitive function [ Time Frame: 48 hours ]
    Assessment of cognitive functions by BrainCheck questionnaire for the investigational product and active comparator product. It involves tests of memory (immediate- and delayed-recall) and of cognitive processing and executive function (digit-symbol substitution, trail-making, Stroop Interference). Once a patient has completed the assessments, the BrainCheck platform immediately provides validated, norm-based scores to the investigators. These scores are adjusted for age, derived from a normative database ranging from ages 10 to 99. Raw scores for the different parameters are scaled and ranked in percentiles. Scores that fall within a range of one standard deviation above the mean (50th percentile) indicate "normal" cognitive function. So, overall scores above 50th percentile are graded normal cognitive function while those below 50th suggest cognitive impairment.

  4. Subjective evaluation of drug effects [ Time Frame: 48 hours ]
    This is done using the Drug-effect questionnaire (DEQ-5) which is a 5-question questionnaire evaluating the effects of the study product. The Five questions assess drug effects, perception and likability. The number and percentage of subjects per response will be presented for each time point according to treatment. Differences between groups will be assessed using a generalized linear mixed model assuming an ordinal response with treatment, time points and treatment by time points as fixed effects and subject as random effect.Outcomes will be summarized using descriptive statistics.


Other Outcome Measures:
  1. Pre-emergent and post-emergent adverse events [ Time Frame: 72 hours ]
    The incidence of pre-emergent and post-emergent adverse events following a single dose of the investigational product and the comparator product. Adverse events are recorded in the study diary.

  2. Blood pressure [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on systolic and diastolic blood pressure

  3. Heart rate [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on heart rate

  4. Alanine aminotransferase (ALT) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on alanine aminotransferase (ALT)

  5. Aspartate aminotransferase (AST) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on aspartate aminotransferase (AST)

  6. Bilirubin [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on bilirubin

  7. Creatinine [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on creatinine

  8. Sodium ion [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on sodium ion

  9. Potassium ion [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on potassium ion

  10. Chloride ion [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on chloride ion

  11. Calcium ion [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on calcium ion

  12. Estimated glomerular filtration rate (eGFR) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on estimated glomerular filtration rate (eGFR)

  13. White blood cell count [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on white blood cell count

  14. Neutrophils [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on neutrophils

  15. Lymphocytes [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on lymphocytes

  16. Monocytes [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on monocytes

  17. Eosinophils [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on eosinophils

  18. Basophils [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on basophils

  19. Red blood cell count [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on red blood cell count

  20. Hemoglobin [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on hemoglobin

  21. Hematocrit [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on hematocrit

  22. Platelet count [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on platelet count

  23. The effect of a single dose of the investigational product and the comparator product on Mean corpuscular volume (MCV) [ Time Frame: 48 hours post dose ]
    Mean corpuscular volume (MCV)

  24. Mean corpuscular hemoglobin (MCH) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on mean corpuscular hemoglobin (MCH)

  25. Mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on mean corpuscular hemoglobin concentration (MCHC)

  26. Red cell distribution width (RDW) [ Time Frame: 48 hours post dose ]
    The effect of a single dose of the investigational product and the comparator product on red cell distribution width (RDW)



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:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provide voluntary, written informed consent to participate in the study
  2. Between 18 and 45 years of age at screening
  3. 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.
  4. Must agree to a 30-day washout of cannabis products prior to baseline.
  5. Willingness to complete questionnaires, records and diaries associated with the study
  6. Have a Body Mass Index (BMI) in the range of 19.0 to 29.9 kg/m2 at baseline
  7. Be willing to provide blood over a 12 h period via an Intravenous (IV) catheter
  8. Blood pressure at screening does not exceed a systolic blood pressure (SBP) of 140 mmHg and a diastolic blood pressure (DBP) of 90 mmHg
  9. 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.
  10. 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
  11. 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
    • 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 (Female subjects whose partners who have had a vasectomy must verbally confirm that their partner's vasectomy was confirmed to be successful by previous assessment of semen samples)
  12. Agree not to donate blood within 30 days after visit 2, visit 3, visit 4 and visit 5
  13. Agrees to refrain from consuming supplements in section 5.3.2 during the study
  14. Agrees not to drive or operate heavy machinery if feeling dizzy or drowsy following drug administration until full mental alertness is regained after treatment visits
  15. 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
  16. Healthy as determined by the following criteria: laboratory results, medical history, physical exam, meeting all the inclusion criteria, not meeting any of the exclusion criteria and not on any concomitant medications listed in Section 5.3. Eligibility will be assessed by the QI based on the above.

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial
  2. Clinically significant abnormal laboratory results at screening as determined by the QI.
  3. Verbal confirmation of hepatic or pancreatic malfunctions
  4. 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.
  5. 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.
  6. 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
  7. Tongue piercings and/or mouth jewelry
  8. 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
  9. 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.
  10. Currently seeking or participating in treatment for substance-related disorders
  11. 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.
  12. 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.
  13. 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.
  14. Verbal confirmation of current or history of bleeding disorders. Will be assessed by QI on a case by case basis depending on the disorder
  15. Participation in a clinical research trial within 30 days prior to randomization
  16. Allergy or sensitivity to investigational product and MCT-diluted cannabis oil ingredients
  17. Verbal confirmation of diabetes and use of diabetes medication. However, eligibility will be assessed by the QI on a case by case basis based on dose and frequency of medication.
  18. Current or previous history of clinically diagnosed neuropsychiatric disorders as per qualified investigator's (QI) opinion
  19. Presence of drugs: amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), nicotine (cotinine), alcohol and THC and metabolites in urine, at screening, baseline and visit 5 (if visit 5 is applicable).
  20. Personal or family history (immediate family) of psychosis: including schizophrenia and affective psychosis
  21. History of suicidal ideation attempts and/or behaviour
  22. Individuals who are cognitively impaired and/or who are unable to give informed consent 23. Verbal confirmation of any autoimmune disease or immune-compromised (i.e. use of anti-rejection medication, rheumatoid arthritis,)

24. Positive laboratory results for HIV, Hepatitis B or C as assessed at screening.

25. Any current or recent active and unstable medical condition that could potentially affect the study objective or adversely affect the participant's ability to complete the study or safety of the subject as per the QI


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): NCT04601207


Locations
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Canada, Ontario
KGK Science Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
New Age Ventures LLC
KGK Science Inc.
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.
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Responsible Party: New Age Ventures LLC
ClinicalTrials.gov Identifier: NCT04601207    
Other Study ID Numbers: 18CBHN
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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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 New Age Ventures LLC:
Cannabis
THC
CBD
Healthy Adult
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders