NCT01526083

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy-volunteers

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

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

January 31, 2012

Last Update Submit

May 4, 2012

Conditions

Healthy Volunteers

Keywords

Male Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

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

    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)

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

  • Maximum Warfarin plasma concentration (Cmax)

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

  • Maximum prothrombin time (PTmax)

    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)

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

  • Warfarin maximum international normalized ratio (INRmax)

    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)

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

Secondary Outcomes (29)

  • Lacosamide trough plasma concentration (Ctrough)

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

  • Time of maximum Warfarin plasma concentration (Tmax)

    Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  • Terminal half-life of Warfarin (T ½)

    Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  • Apparent total body clearance of Warfarin (CL /F)

    Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  • Apparent volume of distribution of Warfarin (V /F)

    Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  • +24 more secondary outcomes

Study Arms (2)

Single dose of Warfarin on day 3

OTHER

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

Other: Lacosamide

Single dose of Warfarin

OTHER
Other: Warfarin

Interventions

LacosamideOTHER

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

Also known as: Vimpat
Single dose of Warfarin on day 3
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

Also known as: Coumadin
Single dose of Warfarin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

001

Zuidlaren, Netherlands

Location

MeSH Terms

Interventions

LacosamideWarfarin

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • UCB Clinical Trial Call Center

    1 877 822 9493

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

NL(1)