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OpenTrials
Completed

NCT Number: NCT01526083

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

001

Zuidlaren, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Other

Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days

Other names: Vimpat

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

Other names: Coumadin

Primary outcomes

  1. 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

  2. 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

  3. Maximum Warfarin plasma concentration (Cmax)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

  4. Maximum prothrombin time (PTmax)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Lacosamide trough plasma concentration (Ctrough)

    Time frame: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing

  2. Time of maximum Warfarin plasma concentration (Tmax)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  3. Terminal half-life of Warfarin (T ½)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  4. Apparent total body clearance of Warfarin (CL /F)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  5. Apparent volume of distribution of Warfarin (V /F)

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  6. First order terminal elimination rate constant of Warfarin

    Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose

  7. CYP2C9 genotype

    Time frame: Single measurement on Day 1

  8. VKORC1 genotype

    Time frame: Single measurement on Day 1

  9. 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

  10. 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

    40-90 bpm

  11. 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

    40-90 bpm

  12. 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

    40-90 bpm

  13. Change from Baseline in Pulse Rate at 4 h post dose

    Time frame: From pre dose to 4 h post dose Lacosamide (LCM) administration

    40-90 bpm

  14. Change from Baseline in Pulse Rate at 12 h post dose

    Time frame: From pre dose to 12 h post dose LCM administration

    40-90 bpm

  15. 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

  16. 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

  17. 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

  18. Change from Baseline in Systolic Blood Pressure at 4 h post dose

    Time frame: From pre dose to 4 h post dose LCM administration

  19. Change from Baseline in Systolic Blood Pressure at 12 h post dose

    Time frame: From pre dose to 12 h post dose LCM administration

    40-90 bpm

  20. 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

  21. 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

  22. 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

  23. Change from Baseline in Diastolic Blood Pressure at 4 h post dose

    Time frame: From pre dose to 4 h post dose LCM administration

  24. Change from Baseline in Diastolic Blood Pressure at 12 h post dose

    Time frame: From pre dose to 12 h post dose LCM administration

    40-90 bpm

  25. 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

  26. 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

  27. 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

  28. Change from Baseline in Body Temperature at 4 h post dose

    Time frame: From pre dose to 4 h post dose LCM administration

  29. Change from Baseline in Body Temperature at 12 h post dose

    Time frame: From pre dose to 12 h post dose LCM administration

    40-90 bpm

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2012
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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