Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Eslicarbazepine acetate; Simvastatin
Intervention MeSH terms: Eslicarbazepine acetate; Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine acetate; simvastatin

Summary:

      The primary objective was to investigate whether multiple-dose administration of ESL 800 mg
      once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.
    

Eligibility 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 ECG; negative tests for HBsAg, anti-HCVAb and 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 uses one of the following methods of contraception: double barrier
             method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm,
             spermicide, or intrauterine device);

          -  If female, has 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

          -  Clinically relevant surgical history;

          -  History of relevant atopy or any drug hypersensitivity (including known
             hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins
             or any of its excipients

          -  History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain

          -  Second or third-degree atrioventricular blockade not corrected with a pacemaker or any
             other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as
             determined by the investigator

          -  History of alcoholism or drug abuse

          -  Consume more than 14 units 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

          -  Have donated or received any blood or blood products within the 3 months prior to
             screening

          -  Vegetarians, vegans or have other medical dietary restrictions

          -  Cannot communicate reliably with the investigator

          -  Unlikely to co-operate with the requirements of the study

          -  Unwilling or unable to give written informed consent

          -  If female, is pregnant or breast-feeding

          -  If female, is of childbearing potential and does not use an approved effective
             contraceptive method (double-barrier method: 1 male barrier method [male condom] plus
             1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses
             hormonal contraceptives

          -  Have received an investigational drug within 3 months of screening or is currently
             participating in another study