The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093
- Registration Number
- NCT02170649
- Lead Sponsor
- Bial - Portela C S.A.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group BIA 2-093 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
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose Maximum observed plasma concentration of BIA 2-093
- Secondary Outcome Measures
Name Time Method 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) 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) of BIA 2-093
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo) 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) of BIA 2-093
Time of Occurrence of Cmax (Tmax) pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose Time of occurrence of Cmax of BIA 2-093