Trial | NCT01526083  Report issue

Title

Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers

  • Phase

    Phase 1

  • Lead Sponsor

    UCB

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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 Started
Jan 31
2012
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
May 07
2012
Estimate

Other Lacosamide

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

  • Other names: Vimpat

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

  • Other names: Coumadin

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

Single dose of Warfarin Other

Criteria 

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
No Results Posted