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

UCB Pharma16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

LacosamideOTHER

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

WarfarinOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

001

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)

Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)

Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period

Maximum Warfarin plasma concentration (Cmax)

Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

Maximum prothrombin time (PTmax)

Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period

Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)

Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period

Warfarin maximum international normalized ratio (INRmax)

Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)

Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

Secondary Outcomes

Lacosamide trough plasma concentration (Ctrough)

Time frame: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing

Data from ClinicalTrials.gov

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Time of maximum Warfarin plasma concentration (Tmax)