- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03936907
Recruitment Status Completed
First Posted May 3, 2019
Last update posted July 24, 2019
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.
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.
|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]
Sativex® Oromucosal Spray
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.-->
- 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
- Subjects receiving concomitant antipsychotic, sedative, hypnotic or other psychoactive
- 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
- 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.
Israel, Israel (isr)
Tel Aviv Sourasky Medical Center
One World Cannabis Ltd.