To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).
This is a double blind, randomized, placebo controlled, two-part study. Part A only will be described in this record. Subjects who satisfy all inclusion and none of the exclusion criteria will begin a 14-day baseline observation period followed by a 14-day treatment period. Subjects will be required to attend six study visits. A follow-up phone call will take place four weeks after last dose. Part A will enroll three groups of 10 subjects: * Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs) * Group 2 - subjects on inhibitor AEDs (and not on inducer AEDs) * Group 3 - subjects on AEDs that are neither inducers nor inhibitors. In each of the three groups subjects will be randomized to receive, in a 4:1 ratio, GWP42006 400 mg twice daily or matching placebo. Pharmacokinetic (PK) profiles for GWP42006 and metabolites will be collected on the first and last day of treatment. Samples will also be collected 24h and 72h after the last day of treatment. Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant AED administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Unnamed facility
Havířov, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Rychnov nad Kněžnou, Czechia
Unnamed facility
Barcelona, Spain
Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.
Time frame: Day 1 to Day 18
Safety and tolerability of GWP42006 (incidence of adverse events).
Time frame: Day -14 to Day 43
The plasma concentration of concomitant AEDs.
Time frame: Day 1 and Day 15
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Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Dundee, United Kingdom
Unnamed facility
Glasgow, United Kingdom
Unnamed facility
Great Yarmouth, United Kingdom
Unnamed facility
Stoke-on-Trent, United Kingdom