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

4. Mai 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

16

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
Sonstiges: Lacosamide
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
Andere Namen:
  • Vimpat
Sonstiges: Single dose of Warfarin
Sonstiges: 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

Andere Namen:
  • Coumadin

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lacosamide trough plasma concentration (Ctrough)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Single measurement on Day 1
Single measurement on Day 1
VKORC1 genotype
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From pre dose to 12 h post dose LCM administration
40-90 bpm
From pre dose to 12 h post dose LCM administration

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

UCB Pharma

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2012

Primärer Abschluss (Tatsächlich)

1. März 2012

Studienabschluss (Tatsächlich)

1. März 2012

Studienanmeldedaten

Zuerst eingereicht

31. Januar 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Februar 2012

Zuerst gepostet (Schätzen)

3. Februar 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

7. Mai 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2012

Zuletzt verifiziert

1. Mai 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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