Healthy Volunteers
Conditions
Keywords
Male Healthy Volunteers
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.
Interventions
OTHERLacosamide
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
OTHERWarfarin
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
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| VKORC1 genotype | Single measurement on Day 1 | — |
| 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 4 h post dose | From pre dose to 4 h post dose Warfarin administration in each treatment period | 40-90 bpm |
| Change from Baseline in Pulse Rate at 12 h post dose | From pre dose to 12 h post dose Warfarin administration in each treatment period | 40-90 bpm |
| 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 Systolic Blood Pressure at 4 h post dose | From pre dose to 4 h post dose Warfarin administration in each treatment period | — |
| Change from Baseline in Systolic Blood Pressure at 12 h post dose | From pre dose to 12 h post dose Warfarin administration in each treatment period | — |
| Lacosamide trough plasma concentration (Ctrough) | Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing | — |
| Change from Baseline in Diastolic Blood Pressure at 4 h post dose | From pre dose to 4 h post dose Warfarin administration in each treatment period | — |
| Change from Baseline in Diastolic Blood Pressure at 12 h post dose | From pre dose to 12 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 | — |
| Change from Baseline in Body Temperature at 4h post dose | From pre dose to 4 h post dose Warfarin administration in each treatment period | — |
| Change from Baseline in Body Temperature at 12 h post dose | From pre dose to 12 h post dose Warfarin administration in each treatment period | — |
| 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 Body Temperature at 4 h post dose | From pre dose to 4 h post dose LCM administration | — |
| 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 | — |
| 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 | — |
| First order terminal elimination rate constant of Warfarin | Multiple sampling from 0 -168 hours following administration of a single Warfarin dose | — |
| CYP2C9 genotype | Single measurement on Day 1 | — |
Countries
Netherlands
Outcome results
None listed