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

BIAL

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: Placebo; Drug: BIA 2-093

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171195

BIA-2093-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 8 patient groups

Group 1 (20 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 2 (50 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 3 (100 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 4 (200 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 5 (400 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 6 (600 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 7 (900 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo

Group 8 (1200 mg)

Experimental group

Treatment:

Drug: BIA 2-093

Drug: Placebo