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A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIA 2-093
Topamax
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)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
  • Male aged of at least 18 years but not older than 45 years with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m
  • Clinical laboratory values within the laboratory's stated normal range; i f not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
  • Healthy according to the medical history, laboratory results and physical
  • Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker i s defined as someone who completely stopped smoking for at least 1 2 months before day 1 of this study

Exclusion Criteria:

  • Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as wel l as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence of significant gastrointestinal, l iver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
  • History of significant gastrointestinal, liver o r kidney disease, o r surgery that may affect drug bioavailability, including but not limited to cholecystectomy
  • Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic d isease
  • Presence o f significant heart disease o r disorder according to ECG
  • Presence or history of significant central nervous system disorder l ike convulsion or depression
  • Presence o r history o f significant ocular disease
  • Presence or history of severe hepatic impairment
  • Presence or history of renal insufficiency (serum creatinine level greater than 135 μmol/L)
  • History or presence of acidosis
  • Use of valproic acid in the previous 7 days prior to Day 1 of the study.
  • Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the previous 28 days before day 1 of this study
  • Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before Day 1 of this study
  • Participation in another clinical trial or donation of 50 mL or more of blood in the previous 28 days before day 1 of this study
  • Donation of 500 mL or more of blood (Canadian B lood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
  • Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4).
  • Positive results to HIV, HBsAg or anti-HCV tests

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A BIA 2-093 + Topamax

    Group B BIA 2-093 + Topamax

    Arm Description

    Group A Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days; Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days

    Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days; Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days; Treatment: 200 mg once daily dose of TPM administered for four consecutive days; Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days

    Outcomes

    Primary Outcome Measures

    Cmax - the Maximum Plasma Concentration
    BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate
    Tmax - the Time of Occurrence of Cmax
    BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups

    Secondary Outcome Measures

    AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.

    Full Information

    First Posted
    November 3, 2014
    Last Updated
    December 19, 2014
    Sponsor
    Bial - Portela C S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02283814
    Brief Title
    A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
    Official Title
    A Phase-1, Open-label, Drug Interaction Study Between Eslicarbazepine Acetate 1200 mg and Topiramate 200 mg Following Multiple Dose Administrations in Healthy Male
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (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
    Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers
    Detailed Description
    Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases

    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
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A BIA 2-093 + Topamax
    Arm Type
    Experimental
    Arm Description
    Group A Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days; Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
    Arm Title
    Group B BIA 2-093 + Topamax
    Arm Type
    Experimental
    Arm Description
    Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days; Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days; Treatment: 200 mg once daily dose of TPM administered for four consecutive days; Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
    Intervention Type
    Drug
    Intervention Name(s)
    BIA 2-093
    Other Intervention Name(s)
    ESL, Eslicarbazepine acetate
    Intervention Type
    Drug
    Intervention Name(s)
    Topamax
    Other Intervention Name(s)
    TPM
    Primary Outcome Measure Information:
    Title
    Cmax - the Maximum Plasma Concentration
    Description
    BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate
    Time Frame
    Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
    Title
    Tmax - the Time of Occurrence of Cmax
    Description
    BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups
    Time Frame
    Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
    Secondary Outcome Measure Information:
    Title
    AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
    Time Frame
    Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer Male aged of at least 18 years but not older than 45 years with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m Clinical laboratory values within the laboratory's stated normal range; i f not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3) Healthy according to the medical history, laboratory results and physical Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker i s defined as someone who completely stopped smoking for at least 1 2 months before day 1 of this study Exclusion Criteria: Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as wel l as severe hypersensitivity reactions (like angioedema) to any drugs Presence of significant gastrointestinal, l iver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects History of significant gastrointestinal, liver o r kidney disease, o r surgery that may affect drug bioavailability, including but not limited to cholecystectomy Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic d isease Presence o f significant heart disease o r disorder according to ECG Presence or history of significant central nervous system disorder l ike convulsion or depression Presence o r history o f significant ocular disease Presence or history of severe hepatic impairment Presence or history of renal insufficiency (serum creatinine level greater than 135 μmol/L) History or presence of acidosis Use of valproic acid in the previous 7 days prior to Day 1 of the study. Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) Any clinically significant illness in the previous 28 days before day 1 of this study Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before Day 1 of this study Participation in another clinical trial or donation of 50 mL or more of blood in the previous 28 days before day 1 of this study Donation of 500 mL or more of blood (Canadian B lood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4). Positive results to HIV, HBsAg or anti-HCV tests

    12. IPD Sharing Statement

    Learn more about this trial

    A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate

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