NCT01879332

A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo tablets for oral administration
DRUG	BIA 2-093 3000 mg once daily	Eslicarbazepine acetate 600 mg tablets for oral administration
DRUG	BIA 2-093 3600 mg once daily	Eslicarbazepine acetate 600 mg tablets for oral administration

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2013-06-17
• Last updated: 2014-12-19
• Results posted: 2014-12-19

Locations

1 site across 1 country: United States