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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Warfarin; Other: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526083

2011-004911-21 (EudraCT Number)

EP0013

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Single dose of Warfarin on day 3

Other group

Description:

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

Treatment:

Other: Lacosamide

Single dose of Warfarin

Other group

Treatment:

Other: Warfarin