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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02170649
• Date of registration: 20/06/2014
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093
• Scientific title: The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 in Healthy Male Volunteers
• Date of first enrolment: September 2001
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02170649
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: BIA 2-093

Primary Outcome(s)

Maximum Observed Plasma Concentration (Cmax) [Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose]

Secondary Outcome(s)

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) [Time Frame: 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 (Tmax) [Time Frame: 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) [Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose]

Secondary ID(s)

BIA-2093-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02170649