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Completed

NCT Number: NCT01375387

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lacosamide

Drug

100 mg oral tablet, single dose

Other names: Vimpat®

Placebo 3

Other

Placebo - 3 tablets

Placebo 4

Other

Placebo - 4 tablets

Placebo 2

Other

Placebo - 2 tablets

Primary outcomes

  1. Maximum drug concentration (Cmax) of lacosamide in plasma.

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  2. 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

  3. 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 outcomes

  1. 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

  2. Terminal half-life (t½) of lacosamide in plasma

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  3. 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

  4. 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

  5. Mean resident time (MRT) of lacosamide in plasma.

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  6. 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

  7. Maximum drug concentration (Cmax) of SPM12809 in plasma.

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  8. 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

  9. 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

  10. 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

  11. Terminal half-life (t½) of SPM12809 in plasma

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  12. 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

  13. 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

  14. 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

  15. Renal clearance (CLR) of lacosamide and SPM12809

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  16. Apparent formation clearance of metabolites (CLfm/F)

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

  17. AUC Ratio

    Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2011
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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