About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers

Clinicaltrials.gov identifier NCT03936907

Recruitment Status Completed

First Posted May 3, 2019

Last update posted July 24, 2019

Study Description

Brief summary:

This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.

  • Condition or Disease:Healthy Subjects
  • Intervention/Treatment: Drug: OWCP Orally Disintegrating Tablet
    Drug: Sativex
  • Phase: Phase 1
Detailed Description

This is a single-center, open-label, single-dose, crossover, randomized, pharmacokinetic study in healthy male adults. Sixsteen (16) subjects will participate in the study. Each subject will undergo screening procedures within 28 days prior to dosing, to assess his eligibility to participate in the study. Eligible subjects will participate in two dosing periods. They will be randomized to one of two administration sequences - AB or BA. In each period subjects will be admitted to the clinic on the evening before dosing. On the next morning, under fasting conditions they will receive one of the following administrations, according to a randomization list: - Administration A: A single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD (Test Formulation) - Administration B: Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] A taste assessment questionnaire will be filled in by the subjects 2 minutes after drug administration (immediately following water administration). Dosing will be followed by Pharmacokinetic (PK ) blood sampling for 24 hours and Adverse Events (AE) monitoring for the next 24 hours, at time points specified below. A washout period of at least 2 weeks is required between the dosings. An End-of Study (EOS)/Safety Follow-up visit will take place 7-10 days after the last dose of study treatment.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 16 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Sequence ABBA
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Orally Disintegrating MGC-ODT Tablet
Administration of a single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD
Drug: OWCP Orally Disintegrating Tablet
Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD
Active Comparator: Sativex®
Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD]
Drug: Sativex
Sativex® Oromucosal Spray
Outcome Measures
  • Primary Outcome Measures: 1. Pharmacokinetic parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
    he amount of time requires for THC, 11-hydroxy-THC and CBD to reach to maximum concentration in serum
  • 2. Pharmacokinetic parameter -Cmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
    Mean highest observed plasma concentration of THC, 11-hydroxy-THC and CBD after dosing.
  • 3. Pharmacokinetic parameter- AUC0-t (area under the plasma concentration-time curve) determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
  • 4. Pharmacokinetic parameter- T½ determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
    The time required for the concentration of THC, 11-hydroxy-THC and CBD to reach half of its original value
  • 5. Pharmacokinetic parameter- kel determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
    Elimination rate constant K - The rate at which THC, 11-hydroxy-THC and CBD are removed from the body determined by their plasma concentration.
  • 6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityof MGC-ODTand Sativex® ] [ Time Frame: 2 weeks post dosing ]
    Safety
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Subjects who provide written informed consent to participate in the study.

- Subjects who agree to have their name and details disclosed to the Israeli Ministry of
Health and other responsible official authorities, as per the local legal requirement
for participation in a THC study.

- Body Mass Index (BMI) ranging from 18 to 14
drinks. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5
ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

Positive urine drug of abuse test on Screening and on admission to the CRC before dosing.

- A positive alcohol breath test on admission to the CRC before dosing.

- History of clinically significant drug allergy; history of atopic allergy (asthma,
urticaria, eczematous dermatitis).

- Any clinically significant abnormality upon physical examination or in the clinical
laboratory tests at the Screening visit.

- Liver disease or liver injury manifested by clinically significant abnormal liver
function tests

- Subjects receiving concomitant antipsychotic, sedative, hypnotic or other psychoactive
drugs.

- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or
dietary supplements including St. John's Wort within 14 days prior to anticipated
dosing; subjects who had treatment with any known enzyme-altering agent (e.g. CYP3A4
inducers or inhibitors), within 30 days of dosing. Paracetamol for symptomatic relief
of pain is allowed until 24 hours prior to study drug administration.

- Any acute illness (e.g. acute infection) within 72 hours prior to study drug
administration that is considered of significance by the Principal Investigator.

- Oral piercing of the tongue, inner lip or cheek.

- Presence of mouth ulcerations or any abnormalities of the oral cavity.

- Unwilling to abstain from smoking throughout the in-house stay at the CRC.

- Unwilling to abstain from alcohol use throughout the in-house stay at the CRC.

- Subjects who refuse to avoid strenuous physical activity throughout in-house stay in
the CRC.

- Participation in another clinical trial with drugs received within 3 months prior to
first dosing (calculated from the previous study's last dosing date).

- Subjects who donated blood in the 3 months or received blood or plasma derivatives in
the 6 months preceding study drug administration.

- Subjects with an inability to communicate well with the investigators and CRC staff
(i.e., language problem, poor mental development or impaired cerebral function).

- Inability to fast or consume the food provided in the study (including any known food
allergies or food restrictions such as lactose intolerance or gluten-free diet).

- Subjects who are non-cooperative or unwilling to attend scheduled clinic visits and/or
comply with the study protocol.

Contacts and Locations
Contacts
Locations

Israel, Israel (isr)
Tel Aviv Sourasky Medical Center
Tel Aviv

Sponsors and Collaborators

One World Cannabis Ltd.

More Information
  • Responsible Party: One World Cannabis Ltd.
  • ClinicalTrials.gov Identifier: NCT03936907 History of Changes
  • Other Study ID Numbers: OWC-ODP12, 20185282
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: July 24, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Marijuana Abuse