NCT01879345

A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers

A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 in Healthy Volunteers

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

Summary

Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Detailed description

Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data. Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093 - 1800 mg (Group 1)	3 tablets of BIA 2-093
DRUG	BIA 2-093 - 2400 mg (Group 2)	4 tablets of BIA 2-093 600 mg
DRUG	Placebo	placebo tablets

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2013-06-17
• Last updated: 2025-04-08
• Results posted: 2014-12-30

Locations

1 site across 1 country: Portugal