Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Other: LacosamideOther: Warfarin
- Registration Number
- NCT01526083
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Single dose of Warfarin on day 3 Lacosamide Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID Single dose of Warfarin Warfarin -
- Primary Outcome Measures
Name Time Method Maximum prothrombin time (PTmax) 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 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 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 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 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 Outcome Measures
Name Time Method 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 CYP2C9 genotype Single measurement on Day 1 VKORC1 genotype Single measurement on Day 1 Change from Baseline in Systolic Blood Pressure at 24 h post dose From pre dose to 24 h post dose Warfarin administration in each treatment period Change from Baseline in Diastolic Blood Pressure at 24 h post dose From pre dose to 24 h post dose Warfarin administration in each treatment period Apparent volume of distribution of Warfarin (V /F) Multiple sampling from 0 -168 hours following administration of a single Warfarin dose First order terminal elimination rate constant of Warfarin Multiple sampling from 0 -168 hours following administration of a single Warfarin dose Change from Baseline in Systolic Blood Pressure at 4 h post dose From pre dose to 4 h post dose LCM administration Change from Baseline in Diastolic Blood Pressure at 12 h post dose From pre dose to 12 h post dose LCM administration 40-90 bpm
Change from Baseline in Body Temperature at 12 h post dose From pre dose to 12 h post dose LCM administration 40-90 bpm
Change from Baseline in Body Temperature at 24 h post dose From pre dose to 24 h post dose Warfarin administration in each treatment period Change from Baseline in Pulse Rate at 4 h post dose From pre dose to 4 h post dose Lacosamide (LCM) administration 40-90 bpm
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study Duration of study is approximately 32 days Change from Baseline in Pulse Rate at 12 h post dose From pre dose to 12 h post dose LCM administration 40-90 bpm
Change from Baseline in Systolic Blood Pressure at 12 h post dose From pre dose to 12 h post dose LCM administration 40-90 bpm
Change from Baseline in Body Temperature at 4 h post dose From pre dose to 4 h post dose LCM administration 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 Change from Baseline in Pulse Rate at 24 h post dose From pre dose to 24 h post dose Warfarin administration in each treatment period 40-90 bpm
Change from Baseline in Diastolic Blood Pressure at 4 h post dose From pre dose to 4 h post dose LCM administration Change from Baseline in Body Temperature at 4h post dose From pre dose to 4 h post dose Warfarin administration in each treatment period
Trial Locations
- Locations (1)
001
🇳🇱Zuidlaren, Netherlands