Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral
      dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects, 18 to 45 years of age, inclusive

          -  Having completed at least high school level education (based on personal report)

          -  Native speakers of the English language or having learned English before 12 years of
             age

          -  Understood and provided written informed consent prior to the initiation of any
             protocol-specific procedures

          -  Body mass index (BMI) was within the range of 18 to 30 kg/m2, inclusive, with a
             minimum weight of at least 50 kg

          -  Free from any clinically significant abnormality on the basis of medical history,
             vital signs, physical examination, 12-lead ECG, and laboratory evaluation at
             Screening.

          -  Female subjects of childbearing potential practiced abstinence or used and were
             willing to continue to use a medically acceptable form of birth control for at least 1
             month prior to Screening and for at least 1 month after the last study drug
             administration. Medically acceptable forms of contraception included intrauterine
             device or double-barrier. Hormone-based contraceptives methods were not acceptable,
             because ESL may have decreased their effectiveness. Female subjects of
             non-childbearing potential were amenorrheic for at least 2 years or had a hysterectomy
             and/or bilateral oophorectomy.

          -  Male subjects were required to use a double-barrier form of contraception

          -  Subjects who were willing and able to abide by all study requirements and restrictions

        Exclusion Criteria:

          -  History or presence of drug or alcohol dependence (excluding nicotine and caffeine),
             including subjects who had ever been in a drug rehabilitation program, based on
             medical history

          -  Clinically significant abnormalities on physical examination, medical history, 12-lead
             ECG, vital signs, or laboratory values, as judged by the investigator or designee

          -  Current psychiatric illness, except nicotine and caffeine dependence. Subjects with a
             past history of psychiatric illness were excluded at the discretion of the
             investigator or designee

          -  History or presence of clinically significant cardiovascular, pulmonary, hepatic,
             renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
             neurologic, oncologic, or psychiatric disease or any other condition, which in the
             opinion of the investigator could jeopardize the safety of the subject or the validity
             of the study results

          -  Use of a non-prescription drug within 7 days prior to the first study drug
             administration. Unless in the opinion of the investigator or designee, the medication
             received did not interfere with the study procedures or data integrity or compromise
             the safety of the subject

          -  Use of any prescription medications or natural health products (except acceptable
             forms of birth control and hormone replacement) within 14 days prior to the first
             study drug administration or throughout the study, unless in the opinion of the
             investigator or designee, the product did not interfere with the study procedures or
             data integrity or compromise the safety of the subject

          -  Positive serum pregnancy screen following Screening or positive urine pregnancy screen
             at admission and on Days -1, 9, or 16

          -  Positive urine drug screen (5-panel MedTox kit) at Screening, Day -1, Day 9, or Day
             16.

          -  Positive breath alcohol test at Screening, Days -1, 9, or 16

          -  Female subjects who were pregnant or lactating or who were planning to become pregnant
             within 60 days of last study drug administration

          -  History of allergy or hypersensitivity to ESL, related drugs, or any of the drug
             excipients or other drug product components

          -  Positive for Hepatitis B, Hepatitis C, or HIV

          -  Current or pending legal charges

          -  Treatment with any investigational drug within 30 days prior to first drug
             administration

          -  A subject who, in the opinion of the investigator or designee, was not considered to
             be suitable and was unlikely to comply with the study protocol for any reason