NCT01375387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
Last Updated

August 23, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

April 19, 2011

Last Update Submit

August 19, 2011

Conditions

Healthy Volunteers

Keywords

VimpatPharmacokineticsHealthy Japanese maleHealthy Chinese male

Outcome Measures

Primary Outcomes (3)

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

    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

    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

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

Secondary Outcomes (17)

  • 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

  • Terminal half-life (t½) of lacosamide in plasma

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

  • Apparent total body clearance (CL/F) of lacosamide in plasma

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

  • Apparent volume of distribution (Vz/F) of lacosamide in plasma

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

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

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

  • +12 more secondary outcomes

Study Arms (8)

Lacosamide 100 mg, Japanese

EXPERIMENTAL

1 Lacosamide 100 mg tablet plus 3 placebo tablets

Drug: LacosamideOther: Placebo 3

Lacosamide 100 mg, Chinese

EXPERIMENTAL

1 Lacosamide 100 mg tablet plus 3 placebo tablets

Drug: LacosamideOther: Placebo 3

Lacosamide 200 mg, Japanese

EXPERIMENTAL

2 Lacosamide 100 mg tablets plus 2 placebo tablets

Drug: LacosamideOther: Placebo 2

Lacosamide 200 mg, Chinese

EXPERIMENTAL

2 Lacosamide 100 mg tablets plus 2 placebo tablets

Drug: LacosamideOther: Placebo 2

Lacosamide 400 mg, Japanese

EXPERIMENTAL

4 Lacosamide 100 mg tablets

Drug: Lacosamide

Lacosamide 400 mg, Chinese

EXPERIMENTAL

4 Lacosamide 100 mg tablets

Drug: Lacosamide

Placebo Comparator, Japanese

PLACEBO COMPARATOR

4 placebo tablets

Other: Placebo 4

Placebo Comparator, Chinese

PLACEBO COMPARATOR

4 placebo tablets

Other: Placebo 4

Interventions

LacosamideDRUG

100 mg oral tablet, single dose

Also known as: Vimpat®
Lacosamide 100 mg, ChineseLacosamide 100 mg, Japanese
Placebo 3OTHER

Placebo - 3 tablets

Lacosamide 100 mg, ChineseLacosamide 100 mg, Japanese
Placebo 4OTHER

Placebo - 4 tablets

Placebo Comparator, ChinesePlacebo Comparator, Japanese
Placebo 2OTHER

Placebo - 2 tablets

Lacosamide 200 mg, ChineseLacosamide 200 mg, Japanese

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese or Japanese volunteers

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2011

First Posted

June 17, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 23, 2011

Record last verified: 2011-06

Locations

DE(1)