Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4 maggio 2012 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
16
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Zuidlaren, Olanda
- 001
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Maschio
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: 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
Altri nomi:
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Altro: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Lacosamide trough plasma concentration (Ctrough)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Single measurement on Day 1
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Single measurement on Day 1
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VKORC1 genotype
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: UCB Clinical Trial Call Center, 1 877 822 9493
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2012
Completamento primario (Effettivo)
1 marzo 2012
Completamento dello studio (Effettivo)
1 marzo 2012
Date di iscrizione allo studio
Primo inviato
31 gennaio 2012
Primo inviato che soddisfa i criteri di controllo qualità
2 febbraio 2012
Primo Inserito (Stima)
3 febbraio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
7 maggio 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 maggio 2012
Ultimo verificato
1 maggio 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EP0013
- 2011-004911-21 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .