- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02287415
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
28. november 2014 oppdatert av: Bial - Portela C S.A.
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Multiple-dose, open-label, single-period study consisting of three consecutive phases
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Fase 1
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 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female subjects aged between 18 and 45 years, inclusive
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive
- Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG
- Subjects who had clinical laboratory tests clinically acceptable
- Subjects who were negative for HBs Ag, anti-HCV Ab and anti-HIV-1 and HIV-2 Ab tests at screening
- Subjects who were negative for alcohol and drugs of abuse at screening
- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day
- Subjects who were able and willing to give written informed consent
- In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device
- In case of female volunteers, subjects who had a negative pregnancy test at screening
Exclusion Criteria:
- Subjects who did not conform to the above inclusion criteria
- Subjects who had a clinically relevant history or presence of respiratory gastrointestinal, renal, hepatic, haematological, lymphatic, neurological cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, endocrine, connective tissue diseases or disorders
- Subjects who had a current haemostatic disorder or a personal or family history of any such disorder
- Subjects who had a personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
- Subjects with a profession or activities implying a special risk of trauma
- Subjects with any abnormality in the coagulation status (aPTT or prothrombin INR)
- Subjects who had a clinically relevant surgical history
- Subjects who had a clinically relevant family history
- Subjects who had a history of relevant atopy
- Subjects who had a history of relevant drug hypersensitivity
- Subjects who had a history of alcoholism or drug abuse
- Subjects who consumed more than 14 units of alcohol a week
- Subjects who had a significant infection or known inflammatory process on screening and/or admission
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn)
- Subjects who had used prescription drugs within 2 weeks prior admission on Phase A
- Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months prior admission to Phase A
- Subjects who had previously received BIA 2-093
- Subjects who had donated and/or received any blood or blood products within the previous 2 months prior admission to Phase A
- Subjects who were vegetarians, vegans and/or had medical dietary restrictions
- Subjects who could not communicate reliably with the investigator
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Group 1
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
|
Andre navn:
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cmax - Maximum Steady-state Plasma Concentration
Tidsramme: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tmax - Time of Occurrence of Cmax
Tidsramme: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval
Tidsramme: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. mai 2002
Primær fullføring (Faktiske)
1. juli 2002
Studiet fullført (Faktiske)
1. juli 2002
Datoer for studieregistrering
Først innsendt
6. november 2014
Først innsendt som oppfylte QC-kriteriene
7. november 2014
Først lagt ut (Anslag)
10. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. november 2014
Sist bekreftet
1. november 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BIA-2093-108
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. .
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