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Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

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ClinicalTrials.gov Identifier: NCT02284854
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

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

Detailed Description:
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Drug: BIA 2-093
Other Names:
  • Eslicarbazepine acetate
  • ESL

Drug: Carbamazepine
Other Name: CBZ

Experimental: Group B
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Drug: BIA 2-093
Other Names:
  • Eslicarbazepine acetate
  • ESL

Drug: Carbamazepine
Other Name: CBZ




Primary Outcome Measures :
  1. Cmax (BIA 2-093) - the Maximum Plasma Concentration [ Time Frame: Day 7 to 35 ]
    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg

  2. Cmax (CBZ) - the Maximum Plasma Concentration [ Time Frame: Day 28 to 35 ]
    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

  3. Cmax (CBZE) - the Maximum Plasma Concentration [ Time Frame: Day 28 to 35 ]

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily

    CBZE - carbamazepine-epoxide is the active metabolite of CBZ


  4. AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093 [ Time Frame: Day 7 to 35 ]
    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg

  5. AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ [ Time Frame: Day 28 to 35 ]
    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

  6. AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE [ Time Frame: Day 28 to 35 ]

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

    CBZE - carbamazepine-epoxide is the active metabolite of CBZ




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18 to 45 years inclusive;
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
  • Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at screening;
  • Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
  • Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
  • Non-smokers or ex-smokers;
  • Able and willing to give written informed consent;
  • If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
  • If female, had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

  • 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; have a clinically relevant surgical history;
  • History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives [e.g., carbamazepine, oxcarbazepine] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);
  • Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;
  • History of alcoholism or drug abuse;
  • Consumed more than 14 units1 of alcohol a week;
  • Significant infection or known inflammatory process on screening or admission to each treatment period;
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
  • Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion;
  • Had donated or received any blood or blood products within the 3 months prior to screening;
  • Vegetarians, vegans or have other medical dietary restrictions;
  • Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;
  • Unwilling or unable to give written informed consent;
  • If female, was pregnant or breast-feeding;
  • If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;
  • Had received an investigational drug within 3 months of screening or was currently participating in another study.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02284854     History of Changes
Other Study ID Numbers: BIA-2093-129
First Posted: November 6, 2014    Key Record Dates
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Carbamazepine
Eslicarbazepine acetate
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Voltage-Gated Sodium Channel Blockers