Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Single dose of Warfarin on day 3

Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID

Group Type OTHER

Lacosamide

Intervention Type OTHER

Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days

Single dose of Warfarin

Group Type OTHER

Warfarin

Intervention Type OTHER

Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period

In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.

Duration: single dose

Interventions

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Lacosamide

Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days

Intervention Type OTHER

Warfarin

Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period

In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.

Duration: single dose

Intervention Type OTHER

Other Intervention Names

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Vimpat Coumadin

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers 18-55 years of age
* BMI 18.0-30.0 kg/m2 and weight at least 50 kg
* Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive

Exclusion Criteria

* Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
* Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
* Volunteer has history of suicide attempt
* Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes