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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIA 2-093
Warfarin
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group 1

    Arm Description

    Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

    Outcomes

    Primary Outcome Measures

    Cmax - Maximum Steady-state Plasma Concentration

    Secondary Outcome Measures

    Tmax - Time of Occurrence of Cmax
    AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval

    Full Information

    First Posted
    November 6, 2014
    Last Updated
    November 28, 2014
    Sponsor
    Bial - Portela C S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02287415
    Brief Title
    The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
    Official Title
    The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    July 2002 (Actual)
    Study Completion Date
    July 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bial - Portela C S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
    Intervention Type
    Drug
    Intervention Name(s)
    BIA 2-093
    Other Intervention Name(s)
    ESL, Eslicarbazepine acetate
    Intervention Type
    Drug
    Intervention Name(s)
    Warfarin
    Other Intervention Name(s)
    Uniwarfin
    Primary Outcome Measure Information:
    Title
    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.
    Secondary Outcome Measure Information:
    Title
    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.
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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