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 Pharma
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 Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
001
Zuidlaren, Netherlands
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center 1 877 822 9493
  More Information

No publications provided

Responsible Party: UCB Pharma
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 Pharma:
Male Healthy Volunteers

Additional relevant MeSH terms:
Lacosamide
Warfarin
Anticoagulants
Anticonvulsants
Central Nervous System Agents
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014