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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01375387
First received: April 19, 2011
Last updated: August 19, 2011
Last verified: June 2011
April 19, 2011
August 19, 2011
March 2011
June 2011   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01375387 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy Volunteers
  • Drug: Lacosamide
    100 mg oral tablet, single dose
    Other Name: Vimpat®
  • Drug: Lacosamide
    Lacosamide 2 X 100 mg tablet
    Other Name: Vimpat®
  • Drug: Lacosamide
    Lacosamide 4 X 100mg tablet
    Other Name: Vimpat®
  • Other: Placebo 3
    Placebo - 3 tablets
  • Other: Placebo 4
    Placebo - 4 tablets
  • Other: Placebo 2
    Placebo - 2 tablets
  • Experimental: Lacosamide 100 mg, Japanese
    1 Lacosamide 100 mg tablet plus 3 placebo tablets
    Interventions:
    • Drug: Lacosamide
    • Other: Placebo 3
  • Experimental: Lacosamide 100 mg, Chinese
    1 Lacosamide 100 mg tablet plus 3 placebo tablets
    Interventions:
    • Drug: Lacosamide
    • Other: Placebo 3
  • Experimental: Lacosamide 200 mg, Japanese
    2 Lacosamide 100 mg tablets plus 2 placebo tablets
    Interventions:
    • Drug: Lacosamide
    • Other: Placebo 2
  • Experimental: Lacosamide 200 mg, Chinese
    2 Lacosamide 100 mg tablets plus 2 placebo tablets
    Interventions:
    • Drug: Lacosamide
    • Other: Placebo 2
  • Experimental: Lacosamide 400 mg, Japanese
    4 Lacosamide 100 mg tablets
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide 400 mg, Chinese
    4 Lacosamide 100 mg tablets
    Intervention: Drug: Lacosamide
  • Placebo Comparator: Placebo Comparator, Japanese
    4 placebo tablets
    Intervention: Other: Placebo 4
  • Placebo Comparator: Placebo Comparator, Chinese
    4 placebo tablets
    Intervention: Other: Placebo 4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2011
June 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01375387
SP1046
2010-023164-40 ( EudraCT Number )
No
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP