NCT02240160

A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: GW Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol (CBD)) by comparing the PK profile of Sativex in healthy subjects. The primary clinical hypothesis is that there will be an effect of oral pH on the PK of Sativex when administered as a single oromucosal dose (four sprays).

Detailed description

This is a Phase I, randomised, open-label, three-way crossover study to assess the effects of oral pH on the PK of Sativex. Subjects will receive each of the following treatments in a random order across three residential treatment visits: * Treatment A (acidic oral pH): Sativex (four sprays) after pre-treatment with Coca-Cola; * Treatment B (neutral oral pH): Sativex (four sprays) after pre-treatment with tap water; * Treatment C (alkaline oral pH): Sativex (four sprays) after pre-treatment with an oral suspension of magnesium hydroxide (milk of magnesia). The target pH for each treatment will be determined from the results of a pilot study. Each dose administration will be separated by at least seven days. Study subjects will participate in a total of five study visits.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Sativex	Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-08-01
• Completion: 2015-10-01
• First posted: 2014-09-15
• Last updated: 2021-02-05