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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375387
• Other study ID #: SP1046
• Secondary ID: 2010-023164-40
• Status: Completed
• Phase: Phase 1
• First received: April 19, 2011
• Last updated: August 19, 2011
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lacosamide
100 mg oral tablet, single dose
• Lacosamide
Lacosamide 2 X 100 mg tablet
• Lacosamide
Lacosamide 4 X 100mg tablet

Other:
• Placebo 3
Placebo - 3 tablets
• Placebo 4
Placebo - 4 tablets
• Placebo 2
Placebo - 2 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum drug concentration (Cmax) of lacosamide in plasma.		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Terminal half-life (t½) of lacosamide in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	Apparent total body clearance (CL/F) of lacosamide in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	Apparent volume of distribution (Vz/F) of lacosamide in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	Mean resident time (MRT) of lacosamide in plasma.		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	First order terminal elimination rate constant (?Z ) of lacosamide in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	Maximum drug concentration (Cmax) of SPM12809 in plasma.		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Terminal half-life (t½) of SPM12809 in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	First order terminal elimination rate constant (?Z ) of SPM12809 in plasma		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	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	No
Secondary	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	No
Secondary	Renal clearance (CLR) of lacosamide and SPM12809		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	Apparent formation clearance of metabolites (CLfm/F)		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No
Secondary	AUC Ratio		Multiple sampling from 0 to 72 hours following single dose in each treatment period	No