A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Placebo; BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epilepsy; BIA 2-093; Eslicarbazepine acetate

Summary:

      The purpose of this study is to investigate the safety and tolerability of multiple dose
      regimens of BIA 2-093 in healthy young male volunteers
    

Eligibility criteria:

        -  Inclusion Criteria:

          -  Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, 12-lead ECG and EEG.

          -  Subjects who had clinical laboratory tests acceptable to the investigator.

          -  Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.

          -  Subjects who were negative for drugs of abuse and alcohol tests at screening and
             admission.

          -  Subjects who were non-smokers or previous smokers who had not smoked for at least 6
             months.

          -  Subjects who were able and willing to give written informed consent.

          -  Exclusion Criteria:

          -  Subjects who did not conform to the above inclusion criteria.

          -  Subjects who had a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, 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 (carbamazepine and

          -  related compounds).

          -  Subjects who had a history of alcoholism.

          -  Subjects who had a history of drug abuse.

          -  Subjects who consumed more than 28 units of alcohol a week.

          -  Subjects who had a significant infection or known inflammatory process on screening
             and/or admission.

          -  Subjects who had acute gastrointestinal symptoms at the time of screening and/or
             admission (e.g. nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who had an acute infection such as influenza at the time of screening and/or
             admission.

          -  Subjects who had used prescription drugs within 4 weeks of first dosing.

          -  Subjects who had used over the counter medication, excluding routine vitamins but
             including mega dose vitamin therapy, within one week of dosing.

          -  Subjects who had used any investigational drug and/or participated in any clinical
             trial within 3 months of admission to this study.

          -  Subjects who had donated and/or received any blood or blood products within 3 months
             prior to screening.

          -  Subjects who were vegetarians, vegans and/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.

          -  Subjects who were unwilling or unable to give written informed consent.

          -  Subjects who had previously received BIA 2-093.