A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093 - 1800 mg (Group 1); BIA 2-093 - 2400 mg (Group 2); Placebo
Intervention description: 3 tablets of BIA 2-093; 4 tablets of BIA 2-093 600 mg; placebo tablets
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anticonvulsant

Summary:

      Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of
      BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male
      volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects aged between 18 and 45 years, inclusive.

          -  Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, vital signs, neurological examination, and 12-lead ECG.

          -  Subjects who had clinical laboratory tests within normal ranges at screening and
             admission.

          -  Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at
             screening.

          -  Subjects who were negative for drugs of abuse and alcohol at screening and admission.

          -  Subjects who were non-smokers or smoked less than 10 cigarettes or equivalent per day.

          -  Subjects who were able and willing to give written informed consent.

        Exclusion Criteria:

          -  Subjects who did not conform to the above inclusion criteria, OR

          -  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 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 or
             admission.

          -  Subjects who had acute gastrointestinal symptoms at the time of screening or admission
             (e.g., nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who had used prescription or over-the-counter medication within 2 weeks of
             admission.

          -  Subjects who had used any investigational drug or participated in any clinical trial
             within 3 months of admission.

          -  Subjects who had previously received BIA 2-093.

          -  Subjects who had donated or received any blood or blood products within the previous 3
             months prior to screening.

          -  Subjects who were vegetarians, vegans or had medical dietary restrictions.

          -  Subjects who could not communicate reliably with the investigator.

          -  Subjects who were unlikely to co-operate with the requirements of the study.