Clinical trial NCT01678976: Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Official title: Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: Eslicarbazepine acetate
Epilepsy
Oxcarbazepine
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Detailed description: Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Eligibility criteria: Inclusion Criteria:

* Male or female 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, and 12-lead ECG.
* Subjects who had clinical laboratory tests acceptable.
* Subjects who were negative for HBs Ag, 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.
* In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
* In case of female volunteers, subjects who had a negative pregnancy test at screening and admission

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 used prescription drugs within 4 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 2 months of their first admission.
* Subjects who had previously received BIA 2-093.
* Subjects who had donated and/or received any blood or blood products within the previous 2 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.
* In case of female volunteers, subjects who were pregnant or breast-feeding.
* In case of female volunteers, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.

Primary outcomes:
measure: Maximum Drug Concentration (Cmax)
timeFrame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Secondary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Other outcomes:
measure: Total of Subjects Reporting at Least One Adverse Event
timeFrame: 4 weeks
Locations:
city: S. Mamede do Coronado
country: Portugal
facility: BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
state: Trofa
Study officials:
affiliation: BIAL - Portela & Cª S.A
name: Manuel Vaz-da-Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: