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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2011

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Lacosamide 100 mg, Japanese
    • 1 Lacosamide 100 mg tablet plus 3 placebo tablets
  • Experimental: Lacosamide 100 mg, Chinese
    • 1 Lacosamide 100 mg tablet plus 3 placebo tablets
  • Experimental: Lacosamide 200 mg, Japanese
    • 2 Lacosamide 100 mg tablets plus 2 placebo tablets
  • Experimental: Lacosamide 200 mg, Chinese
    • 2 Lacosamide 100 mg tablets plus 2 placebo tablets
  • Experimental: Lacosamide 400 mg, Japanese
    • 4 Lacosamide 100 mg tablets
  • Experimental: Lacosamide 400 mg, Chinese
    • 4 Lacosamide 100 mg tablets
  • Placebo Comparator: Placebo Comparator, Japanese
    • 4 placebo tablets
  • Placebo Comparator: Placebo Comparator, Chinese
    • 4 placebo tablets

Clinical Trial Outcome Measures

Primary Measures

  • Maximum drug concentration (Cmax) of lacosamide in plasma.
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

Secondary Measures

  • Time to reach maximum plasma concentration (tmax) of lacosamide in plasma
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Terminal half-life (t½) of lacosamide in plasma
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Apparent total body clearance (CL/F) of lacosamide in plasma
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Apparent volume of distribution (Vz/F) of lacosamide in plasma
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Mean resident time (MRT) of lacosamide in plasma.
    • Time Frame: 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
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Maximum drug concentration (Cmax) of SPM12809 in plasma.
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Terminal half-life (t½) of SPM12809 in plasma
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Renal clearance (CLR) of lacosamide and SPM12809
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • Apparent formation clearance of metabolites (CLfm/F)
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
  • AUC Ratio
    • Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • UCB Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.