The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.

Detailed Description
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Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.

Official Title
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The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 in Healthy Male Volunteers

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: BIA 2-093


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria: Male subjects aged between 18 and 45 years, inclusive. Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive. Subjects who were healthy as determined by pre study medical history, physical examination, neurological examination, EEG, and 12-lead ECG. Subjects who had clinical laboratory tests clinically acceptable to the investigator. Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening. Subjects who were negative for alcohol and drugs of abuse 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. Subjects who had a history of alcoholism or drug abuse. Subjects who consumed more than 21 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 four weeks of first dosing. Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing. Subjects who had used any investigational drug and/or participated in any clinical trial within two months of their first admission to this study. Subjects who had previously received BIA 2-093. Subjects who had donated and/or received any blood or blood products within the previous two 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group<br>the volunteers received a single 800 mg BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period | Drug: BIA 2-093<br> <br> * Other names: ESL, Eslicarbazepine acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration of BIA 2-093 | pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Occurrence of Cmax (Tmax) | Time of occurrence of Cmax of BIA 2-093 | pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose | 
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t) | Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093 | pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose | 
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo) | Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093 | pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BIA 2-093, Eslicarbazepine acetate