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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004911-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Other | Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 1 877 822 9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 001 | Zuidlaren | Netherlands |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Warfarin | Other | 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 |
|
|
| 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 |
| 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 | 40-90 bpm | From pre dose to 4 h post dose Warfarin administration in each treatment period |
| Change from Baseline in Pulse Rate at 12 h post dose | 40-90 bpm | From pre dose to 12 h post dose Warfarin administration in each treatment period |
| Change from Baseline in Pulse Rate at 24 h post dose | 40-90 bpm | 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 | 40-90 bpm | From pre dose to 4 h post dose Lacosamide (LCM) administration |
| Change from Baseline in Pulse Rate at 12 h post dose | 40-90 bpm | From pre dose to 12 h post dose LCM administration |
| 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 |
| 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 Systolic Blood Pressure at 4 h post dose | From pre dose to 4 h post dose LCM administration |
| Change from Baseline in Systolic Blood Pressure at 12 h post dose | 40-90 bpm | From pre dose to 12 h post dose LCM administration |
| 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 Diastolic 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 | 40-90 bpm | From pre dose to 12 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 |
| 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 Body Temperature at 12 h post dose | 40-90 bpm | From pre dose to 12 h post dose LCM administration |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |