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

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Other: Lacosamide Other: Warfarin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin sodium Lacosamide

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Maximum Warfarin plasma concentration (Cmax) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Maximum prothrombin time (PTmax) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Warfarin area under the prothrombin time (PT) versus time curve (PTAUC) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Warfarin maximum international normalized ratio (INRmax) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period ] [ Designated as safety issue: No ]
Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lacosamide trough plasma concentration (Ctrough) [ Time Frame: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing ] [ Designated as safety issue: No ]
Time of maximum Warfarin plasma concentration (Tmax) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose ] [ Designated as safety issue: No ]
Terminal half-life of Warfarin (T ½) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose ] [ Designated as safety issue: No ]
Apparent total body clearance of Warfarin (CL /F) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose ] [ Designated as safety issue: No ]
Apparent volume of distribution of Warfarin (V /F) [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose ] [ Designated as safety issue: No ]
First order terminal elimination rate constant of Warfarin [ Time Frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose ] [ Designated as safety issue: No ]
CYP2C9 genotype [ Time Frame: Single measurement on Day 1 ] [ Designated as safety issue: No ]
VKORC1 genotype [ Time Frame: Single measurement on Day 1 ] [ Designated as safety issue: No ]
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study [ Time Frame: Duration of study is approximately 32 days ] [ Designated as safety issue: No ]
Change from Baseline in Pulse Rate at 4 h post dose [ Time Frame: From pre dose to 4 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Pulse Rate at 12 h post dose [ Time Frame: From pre dose to 12 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Pulse Rate at 24 h post dose [ Time Frame: From pre dose to 24 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Pulse Rate at 4 h post dose [ Time Frame: From pre dose to 4 h post dose Lacosamide (LCM) administration ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Pulse Rate at 12 h post dose [ Time Frame: From pre dose to 12 h post dose LCM administration ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Systolic Blood Pressure at 4 h post dose [ Time Frame: From pre dose to 4 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Systolic Blood Pressure at 12 h post dose [ Time Frame: From pre dose to 12 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Systolic Blood Pressure at 24 h post dose [ Time Frame: From pre dose to 24 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Systolic Blood Pressure at 4 h post dose [ Time Frame: From pre dose to 4 h post dose LCM administration ] [ Designated as safety issue: No ]
Change from Baseline in Systolic Blood Pressure at 12 h post dose [ Time Frame: From pre dose to 12 h post dose LCM administration ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Diastolic Blood Pressure at 4 h post dose [ Time Frame: From pre dose to 4 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Diastolic Blood Pressure at 12 h post dose [ Time Frame: From pre dose to 12 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Diastolic Blood Pressure at 24 h post dose [ Time Frame: From pre dose to 24 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Diastolic Blood Pressure at 4 h post dose [ Time Frame: From pre dose to 4 h post dose LCM administration ] [ Designated as safety issue: No ]
Change from Baseline in Diastolic Blood Pressure at 12 h post dose [ Time Frame: From pre dose to 12 h post dose LCM administration ] [ Designated as safety issue: No ]
40-90 bpm
Change from Baseline in Body Temperature at 4h post dose [ Time Frame: From pre dose to 4 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Body Temperature at 12 h post dose [ Time Frame: From pre dose to 12 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Body Temperature at 24 h post dose [ Time Frame: From pre dose to 24 h post dose Warfarin administration in each treatment period ] [ Designated as safety issue: No ]
Change from Baseline in Body Temperature at 4 h post dose [ Time Frame: From pre dose to 4 h post dose LCM administration ] [ Designated as safety issue: No ]
Change from Baseline in Body Temperature at 12 h post dose [ Time Frame: From pre dose to 12 h post dose LCM administration ] [ Designated as safety issue: No ]
40-90 bpm

Enrollment:	16
Study Start Date:	January 2012
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single dose of Warfarin on day 3 Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID	Other: Lacosamide Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days Other Name: Vimpat
Single dose of Warfarin	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 Name: Coumadin

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526083

Locations

Netherlands
001
Zuidlaren, Netherlands

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

1 877 822 9493

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01526083 History of Changes
Other Study ID Numbers:	EP0013, 2011-004911-21
Study First Received:	January 31, 2012
Last Updated:	May 4, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UCB, Inc.:

Male Healthy Volunteers

Additional relevant MeSH terms:

Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013