GW-Effect of severe renal impairment on pharmacokinetics of Sativex®
Research type
Research Study
Full title
An open-label, single-dose study to compare the pharmacokinetics (PK) of an oromucosal dose of four sprays of Sativex® in subjects with severe renal impairment or end stage renal disease (ESRD) not requiring dialysis, compared to matched subjects with normal renal function.
IRAS ID
162454
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
GW Pharma Ltd
Eudract number
2014-003104-67
Duration of Study in the UK
0 years, 10 months, 1 days
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.
As part of the ongoing development of Sativex®, further clinical trials are being conducted to determine the medications’ safety in various clinical scenarios. This particular trial is looking at if alterations in the kidney function have an effect on how the body handles (absorbs, distributes, breaks down and eliminates) a single dose of Sativex® when sprayed into the mouth.
Previous studies have shown that Sativex® is removed from the body predominantly through the liver. However, sometimes significant kidney impairment can impact on how the liver processes medications and this study is being conducted in order to determine the effect kidney impairment can have on how the body processes Sativex®.
This will be investigated by comparing the blood profile of its main active ingredients in patients with severe renal impairment (but not requiring dialysis) compared to healthy volunteers (matched for age, sex, height and weight). Blood levels of the main components of Sativex® will be used to estimate mathematical descriptors (so-called “pharmacokinetic parameters”) that define how the body handles Sativex®. These will be compared between the patients and healthy volunteers, in order to determine whether kidney impairment influences the way Sativex® is handled. This will help to decide whether the dose of Sativex® needs to be modified in patients with kidney failure.
We shall also assess the safety and tolerability of single doses of Sativex® in the same patients.
REC name
HSC REC B
REC reference
15/NI/0075
Date of REC Opinion
20 May 2015
REC opinion
Favourable Opinion