NCT01375387

Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males

A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lacosamide	100 mg oral tablet, single dose
DRUG	Lacosamide	Lacosamide 2 X 100 mg tablet
DRUG	Lacosamide	Lacosamide 4 X 100mg tablet
OTHER	Placebo 3	Placebo - 3 tablets
OTHER	Placebo 4	Placebo - 4 tablets
OTHER	Placebo 2	Placebo - 2 tablets

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-06-17
• Last updated: 2011-08-23

Locations

1 site across 1 country: Germany