GE Blakey, P McCormack, ADP Dean and N Entwistle
Astra Charnwood, Loughborough, Leicestershire, LEl l 5RH, UK
Remacemide is in Phase III development for use in the treatment of epilepsy. Both remacemide and its active desglycinyl metabolite have low affinity, non-competitive NMDA receptor channel blocking properties.
This prospective NONMEM analysis is concerned with remacemide plasma concentration data generated by 197 patients in a phase IIb dose ranging study. Patients were randomised to receive either 300, 600 or 800 mg of remacemide hydrochloride daily in a bid regimen. All patients were taking at least one concomitant enzyme inducing anti-epileptic drug.
A 2 compartment model with first order absorption was used in the analysis of the data. The influence of demographic co-variates including age, weight and gender on the estimates variance parameters will be presented. These results will be compared with findings from phase I studies which have indicated that remacemide clearance was independent of age and gender in healthy volunteers. Furthermore, these exploratory results will aid in deducing the degree of induction and the spectrum of concomitant medication influence that is likely to be encountered in the future Phase III studies.
Reference: PAGE 7 () Abstr 682 [www.page-meeting.org/?abstract=682]
Poster: poster