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

NCT ID: NCT02171195

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2000-10-31

Brief 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.

Detailed Description

Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1 (20 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 2 (50 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 3 (100 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 4 (200 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 5 (400 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 6 (600 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 7 (900 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Group 8 (1200 mg)

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebo

Intervention Type: DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Interventions

BIA 2-093

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Intervention Type: DRUG

Placebo

Identical placebo administered as oral tablets with 200 ml potable water.

Intervention Type: DRUG

Other Intervention Names

ESL, Eslicarbazepine acetate; PLC

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guy's Drug Research Unit

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

BIA-2093-101

Identifier Type: -

Identifier Source: org_study_id