Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4. mai 2012 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Zuidlaren, Nederland
- 001
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
|
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
Andre navn:
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Annen: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
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Maximum prothrombin time (PTmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
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Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lacosamide trough plasma concentration (Ctrough)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
|
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First order terminal elimination rate constant of Warfarin
Tidsramme: 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
Tidsramme: Single measurement on Day 1
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Single measurement on Day 1
|
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VKORC1 genotype
Tidsramme: 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
Tidsramme: 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
Tidsramme: From pre dose to 4 h post dose Warfarin administration in each treatment period
|
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
Tidsramme: From pre dose to 12 h post dose Warfarin administration in each treatment period
|
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
Tidsramme: From pre dose to 24 h post dose Warfarin administration in each treatment period
|
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
Tidsramme: 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
Tidsramme: From pre dose to 12 h post dose LCM administration
|
40-90 bpm
|
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
Tidsramme: 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
|
|
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Change from Baseline in Systolic Blood Pressure at 12 h post dose
Tidsramme: 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
Tidsramme: 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
|
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Change from Baseline in Systolic Blood Pressure at 4 h post dose
Tidsramme: 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
Tidsramme: From pre dose to 12 h post dose LCM administration
|
40-90 bpm
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From pre dose to 12 h post dose LCM administration
|
40-90 bpm
|
From pre dose to 12 h post dose LCM administration
|
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Change from Baseline in Body Temperature at 4h post dose
Tidsramme: 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
|
|
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Change from Baseline in Body Temperature at 12 h post dose
Tidsramme: 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
|
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Change from Baseline in Body Temperature at 24 h post dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: From pre dose to 12 h post dose LCM administration
|
40-90 bpm
|
From pre dose to 12 h post dose LCM administration
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: UCB Clinical Trial Call Center, 1 877 822 9493
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2012
Primær fullføring (Faktiske)
1. mars 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
31. januar 2012
Først innsendt som oppfylte QC-kriteriene
2. februar 2012
Først lagt ut (Anslag)
3. februar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. mai 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2012
Sist bekreftet
1. mai 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EP0013
- 2011-004911-21 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .