Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4 mei 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Zuidlaren, Nederland
- 001
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
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Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
Andere namen:
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Ander: Single dose of Warfarin
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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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Maximum Warfarin plasma concentration (Cmax)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Maximum prothrombin time (PTmax)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Warfarin maximum international normalized ratio (INRmax)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lacosamide trough plasma concentration (Ctrough)
Tijdsspanne: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
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Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
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Time of maximum Warfarin plasma concentration (Tmax)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Terminal half-life of Warfarin (T ½)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Apparent total body clearance of Warfarin (CL /F)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Apparent volume of distribution of Warfarin (V /F)
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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First order terminal elimination rate constant of Warfarin
Tijdsspanne: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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CYP2C9 genotype
Tijdsspanne: Single measurement on Day 1
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Single measurement on Day 1
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VKORC1 genotype
Tijdsspanne: Single measurement on Day 1
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Single measurement on Day 1
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Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
Tijdsspanne: Duration of study is approximately 32 days
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Duration of study is approximately 32 days
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Change from Baseline in Pulse Rate at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 24 h post dose
Tijdsspanne: From pre dose to 24 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose Lacosamide (LCM) administration
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40-90 bpm
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From pre dose to 4 h post dose Lacosamide (LCM) administration
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Change from Baseline in Pulse Rate at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Systolic Blood Pressure at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 24 h post dose
Tijdsspanne: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Systolic Blood Pressure at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 24 h post dose
Tijdsspanne: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Body Temperature at 4h post dose
Tijdsspanne: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 24 h post dose
Tijdsspanne: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 4 h post dose
Tijdsspanne: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Body Temperature at 12 h post dose
Tijdsspanne: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: UCB Clinical Trial Call Center, 1 877 822 9493
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2012
Primaire voltooiing (Werkelijk)
1 maart 2012
Studie voltooiing (Werkelijk)
1 maart 2012
Studieregistratiedata
Eerst ingediend
31 januari 2012
Eerst ingediend dat voldeed aan de QC-criteria
2 februari 2012
Eerst geplaatst (Schatting)
3 februari 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
7 mei 2012
Laatste update ingediend die voldeed aan QC-criteria
4 mei 2012
Laatst geverifieerd
1 mei 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EP0013
- 2011-004911-21 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .