NCT01975688

A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis

An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GW Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics \[PKs\] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.

Conditions

• Head and Neck Squamous Cell Carcinoma

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 vial contains 10 mL; each 100 uL actuation delivers 2.7 mg THC and 2.5 mg CBD.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2013-11-05
• Last updated: 2016-08-11

Locations

1 site across 1 country: United Kingdom