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

4 maj 2012 uppdaterad av: UCB Pharma

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

16

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
Övrig: Lacosamide
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
Andra namn:
  • Vimpat
Övrig: Single dose of Warfarin
Övrig: 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

Andra namn:
  • Coumadin

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Maximum Warfarin plasma concentration (Cmax)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Maximum prothrombin time (PTmax)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin maximum international normalized ratio (INRmax)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lacosamide trough plasma concentration (Ctrough)
Tidsram: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Time of maximum Warfarin plasma concentration (Tmax)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Terminal half-life of Warfarin (T ½)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent total body clearance of Warfarin (CL /F)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent volume of distribution of Warfarin (V /F)
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
First order terminal elimination rate constant of Warfarin
Tidsram: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
CYP2C9 genotype
Tidsram: Single measurement on Day 1
Single measurement on Day 1
VKORC1 genotype
Tidsram: Single measurement on Day 1
Single measurement on Day 1
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
Tidsram: Duration of study is approximately 32 days
Duration of study is approximately 32 days
Change from Baseline in Pulse Rate at 4 h post dose
Tidsram: From pre dose to 4 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 12 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 24 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 4 h post dose Lacosamide (LCM) administration
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
Tidsram: From pre dose to 12 h post dose LCM administration
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
Tidsram: From pre dose to 4 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 12 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 24 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 12 h post dose
Tidsram: From pre dose to 12 h post dose LCM administration
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
Tidsram: From pre dose to 4 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 12 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 24 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Tidsram: From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration
Change from Baseline in Body Temperature at 4h post dose
Tidsram: From pre dose to 4 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 12 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 24 h post dose Warfarin administration in each treatment period
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
Tidsram: From pre dose to 4 h post dose LCM administration
From pre dose to 4 h post dose LCM administration
Change from Baseline in Body Temperature at 12 h post dose
Tidsram: From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UCB Pharma

Utredare

  • Studierektor: UCB Clinical Trial Call Center, 1 877 822 9493

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2012

Primärt slutförande (Faktisk)

1 mars 2012

Avslutad studie (Faktisk)

1 mars 2012

Studieregistreringsdatum

Först inskickad

31 januari 2012

Först inskickad som uppfyllde QC-kriterierna

2 februari 2012

Första postat (Uppskatta)

3 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 maj 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2012

Senast verifierad

1 maj 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EP0013
  • 2011-004911-21 (EudraCT-nummer)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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