Effect of pH on the PK of sativex
Research type
Research Study
Full title
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.
IRAS ID
151232
Contact name
James Ritter
Contact email
Sponsor organisation
GW Pharmaceuticals
Eudract number
2013-004459-19
Research summary
Sativex® (a medically licensed extract of cannabis plants) is used as an adjunctive pain treatment in patients with advanced cancer or spasticity in multiple sclerosis and adjunctive treatment for symptomatic relief of neuropathic pain (nerve pain) in multiple sclerosis.
Sativex® is administered as a spray into the mouth, and changes in the level of acid in the mouth (oral pH) occurring e.g. as a consequence of cancer treatment may affect the absorption of Sativex® and there may be a need to adjust the dose in patients.
The main objective of this study is to address this by evaluating the effect of oral pH on how the body handles (absorbs, distributes, breaks down and eliminates) a single dose of Sativex® sprayed into the mouth.
This will be investigated by comparing the blood profile of its main active ingredients in healthy volunteers by using 3 different pre-treatment agents (Coca-cola, Tap water and liquid antacid medication) to alter the oral pH.
This study will be done in 2 parts: Pilot study and Main study. The pilot study will be done to investigate the magnitude and duration of the oral pH change induced by each of three test conditions that will be used to alter oral pH in the main part of the study. The study drug will not be administered to volunteers in the Pilot study.
The pilot study will involve 4 study visits (screening and 3 out-patient visits). The main study will involve five study visits (screening, 3 in-patient treatment visits and follow-up).
We shall also assess the safety and tolerability of single doses of Sativex® in the same volunteers (main study).
Blood levels of the main components of Sativex® will be used to estimate mathematical descriptors (“pharmacokinetic parameters”) that define how the body handles Sativex® at 3 different oral pH conditions.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1006
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion