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The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02287415
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE November 6, 2014
First Posted Date  ICMJE November 10, 2014
Results First Submitted Date  ICMJE November 28, 2014
Results First Posted Date  ICMJE December 1, 2014
Last Update Posted Date December 1, 2014
Study Start Date  ICMJE May 2002
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
Cmax - Maximum Steady-state Plasma Concentration [ Time Frame: 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
  • Tmax - Time of Occurrence of Cmax [ Time Frame: 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 [ Time Frame: 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
Official Title  ICMJE The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Brief Summary Multiple-dose, open-label, single-period study consisting of three consecutive phases
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: BIA 2-093
    Other Name: ESL, Eslicarbazepine acetate
  • Drug: Warfarin
    Other Name: Uniwarfin
Study Arms  ICMJE Experimental: Group 1
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
Interventions:
  • Drug: BIA 2-093
  • Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2014)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2002
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02287415
Other Study ID Numbers  ICMJE BIA-2093-108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP