NCT02171195

A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093

A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 When Given to Healthy Male Adult Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.

Detailed description

Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
DRUG	Placebo	Identical placebo administered as oral tablets with 200 ml potable water.

Timeline

• Start date: 2000-07-01
• Primary completion: 2000-10-01
• Completion: 2000-10-01
• First posted: 2014-06-24
• Last updated: 2016-07-20
• Results posted: 2015-01-07

Locations

1 site across 1 country: United Kingdom