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- Essai clinique NCT01526083
Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4 mai 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
16
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Zuidlaren, Pays-Bas
- 001
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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
Autres noms:
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Autre: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Lacosamide trough plasma concentration (Ctrough)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Single measurement on Day 1
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Single measurement on Day 1
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VKORC1 genotype
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: UCB Clinical Trial Call Center, 1 877 822 9493
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2012
Achèvement primaire (Réel)
1 mars 2012
Achèvement de l'étude (Réel)
1 mars 2012
Dates d'inscription aux études
Première soumission
31 janvier 2012
Première soumission répondant aux critères de contrôle qualité
2 février 2012
Première publication (Estimation)
3 février 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 mai 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mai 2012
Dernière vérification
1 mai 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EP0013
- 2011-004911-21 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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