- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02287415
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
28 november 2014 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Group 1
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
|
Andra namn:
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Cmax - Maximum Steady-state Plasma Concentration
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Tmax - Time of Occurrence of Cmax
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2002
Primärt slutförande (Faktisk)
1 juli 2002
Avslutad studie (Faktisk)
1 juli 2002
Studieregistreringsdatum
Först inskickad
6 november 2014
Först inskickad som uppfyllde QC-kriterierna
7 november 2014
Första postat (Uppskatta)
10 november 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BIA-2093-108
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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