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Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

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ClinicalTrials.gov Identifier: NCT02283827
Recruitment Status : Completed
First Posted : November 5, 2014
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: Phenytoin Phase 1

Detailed Description:

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design:

Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;

Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Phenytoin 300 mg Following Multiple Dose Administrations in Healthy Male Volunteers
Study Start Date : January 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007


Arm Intervention/treatment
Experimental: Group A BIA 2-093 + Phenytoin (PHT)
Day 1 to 2: Pre-treatment 1: 600 mg ESL Day 3 to 8: Treatment 1: 1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ 100 mg PHT Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT
Drug: BIA 2-093
Other Names:
  • Eslicarbazepine acetate
  • ESL

Drug: Phenytoin
Other Name: PHT

Experimental: Group B BIA 2-093 + Phenytoin (PHT)
Day 1 to 2: Pre-treatment 2: 100 mg PHT Day 3 to 8: Treatment 2: 300 mg PHT Day 9 to 10: Treatment 2 + Pre-treatment 1: 300 mg PHT + 600 mg ESL Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT
Drug: BIA 2-093
Other Names:
  • Eslicarbazepine acetate
  • ESL

Drug: Phenytoin
Other Name: PHT




Primary Outcome Measures :
  1. Cmax - the Maximum Plasma Concentration [ Time Frame: 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 ]
    BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate


Secondary Outcome Measures :
  1. AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time [ Time Frame: 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 ]

    AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time

    BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate


  2. Tmax - the Time of Occurrence of Cmax [ Time Frame: 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 ]
    BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • Non-black male aged of at least 18 years but not older than 45 years with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m2
  • Clinical laboratory values within the laboratory's stated normal range; if 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 examination
  • Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study

Exclusion Criteria:

  • Significant history of hypersensitivity to phenytoin, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence of significant gastrointestinal, liver 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 or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
  • Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of significant heart disease or disorder according to ECG
  • Presence or history of significant central nervous system disorder like convulsion or depression
  • Hemoglobin count below 135 g/L (at screening)
  • 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.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02283827     History of Changes
Other Study ID Numbers: BIA-2093-121
First Posted: November 5, 2014    Key Record Dates
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Eslicarbazepine acetate
Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers