A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Placebo
Intervention description: BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg; Identical placebo administered as oral tablets with 200 ml potable water.
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: 64.0
Sex: Male
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine acetate; BIA 2-093; Epilepsy

Summary:

      The purpose of this study is to determine the safety and tolerability of single rising oral
      doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg)
      in groups of 8 healthy male adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

        Adult males aged 18-35 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 who 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.

          -  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 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.