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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01526083
First received: January 31, 2012
Last updated: May 4, 2012
Last verified: May 2012
  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:


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 April 17, 2014