Conditions: Epilepsy
Keywords: Anticonvulsant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: yes

Brief summary:
Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

Detailed description:
This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days.

A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites.

Arms:
arm 1: Matching placebo tablets for oral administration arm 2: Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets) arm 3: Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)

Interventions: intervention 1: Placebo intervention 2: BIA 2-093 3000 mg once daily intervention 3: BIA 2-093 3600 mg once daily
Intervention descriptions: intervention 1: Matching placebo tablets for oral administration intervention 2: Eslicarbazepine acetate 600 mg tablets for oral administration intervention 3: Eslicarbazepine acetate 600 mg tablets for oral administration

Protocol document: