drugset / Trial / NCT01975688

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

NCT01975688

Phase 1 Terminated 10 enrolled GW Pharmaceuticals Ltd
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-02
Primary completion
2015-03
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nabiximols Other / unclassified 10 mg Other
Subject Nabiximols Other / unclassified 10.8 mg Other