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

Healthy Subjects Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT03936907
• Study type: Interventional
• Source: One World Cannabis Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2019
• Completion date: July 18, 2019