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

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate

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.