Clinical trial NCT01375387: Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Vimpat
Pharmacokinetics
Healthy Japanese male
Healthy Chinese male
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximum drug concentration (Cmax) of lacosamide in plasma.
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Secondary outcomes:
measure: Time to reach maximum plasma concentration (tmax) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Terminal half-life (t½) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Apparent total body clearance (CL/F) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Apparent volume of distribution (Vz/F) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Mean resident time (MRT) of lacosamide in plasma.
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: First order terminal elimination rate constant (λZ ) of lacosamide in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Maximum drug concentration (Cmax) of SPM12809 in plasma.
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Terminal half-life (t½) of SPM12809 in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: First order terminal elimination rate constant (λZ ) of SPM12809 in plasma
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Fraction of dose excreted in urine (fe) of lacosamide and SPM12809
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Renal clearance (CLR) of lacosamide and SPM12809
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: Apparent formation clearance of metabolites (CLfm/F)
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
measure: AUC Ratio
timeFrame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: