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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Lacosamide; Drug: Lacosamide; Drug: Lacosamide; Other: Placebo 3; Other: Placebo 2; Other: Placebo 4

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy Chinese or Japanese volunteers

Exclusion Criteria:

• Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
• Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lacosamide 100 mg, Japanese; 1 Lacosamide 100 mg tablet plus 3 placebo tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®; Other: Placebo 3; Placebo - 3 tablets
EXPERIMENTAL: Lacosamide 100 mg, Chinese; 1 Lacosamide 100 mg tablet plus 3 placebo tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®; Other: Placebo 3; Placebo - 3 tablets
EXPERIMENTAL: Lacosamide 200 mg, Japanese; 2 Lacosamide 100 mg tablets plus 2 placebo tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®; Other: Placebo 2; Placebo - 2 tablets
EXPERIMENTAL: Lacosamide 200 mg, Chinese; 2 Lacosamide 100 mg tablets plus 2 placebo tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®; Other: Placebo 2; Placebo - 2 tablets
EXPERIMENTAL: Lacosamide 400 mg, Japanese; 4 Lacosamide 100 mg tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®
EXPERIMENTAL: Lacosamide 400 mg, Chinese; 4 Lacosamide 100 mg tablets	Drug: Lacosamide; 100 mg oral tablet, single dose; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 2 X 100 mg tablet; Other Names: Vimpat®; Drug: Lacosamide; Lacosamide 4 X 100mg tablet; Other Names: Vimpat®
PLACEBO_COMPARATOR: Placebo Comparator, Japanese; 4 placebo tablets	Other: Placebo 4; Placebo - 4 tablets
PLACEBO_COMPARATOR: Placebo Comparator, Chinese; 4 placebo tablets	Other: Placebo 4; Placebo - 4 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum drug concentration (Cmax) of lacosamide in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach maximum plasma concentration (tmax) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent total body clearance (CL/F) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent volume of distribution (Vz/F) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Mean resident time (MRT) of lacosamide in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Maximum drug concentration (Cmax) of SPM12809 in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Fraction of dose excreted in urine (fe) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Renal clearance (CLR) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent formation clearance of metabolites (CLfm/F)	Multiple sampling from 0 to 72 hours following single dose in each treatment period
AUC Ratio	Multiple sampling from 0 to 72 hours following single dose in each treatment period

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (ESTIMATE): June 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Vimpat; Healthy Japanese male; Healthy Chinese male
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP1046; 2010-023164-40 (EUDRACT_NUMBER)