Clinical trial NCT02284854: Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Official title: Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Detailed description: Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 18 to 45 years inclusive;
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
* Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at screening;
* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
* Non-smokers or ex-smokers;
* Able and willing to give written informed consent;
* If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method \[male condom\] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
* If female, had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders; have a clinically relevant surgical history;
* History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives \[e.g., carbamazepine, oxcarbazepine\] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine \[e.g.: tricyclic antidepressants\] or any of its excipients);
* Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;
* History of alcoholism or drug abuse;
* Consumed more than 14 units1 of alcohol a week;
* Significant infection or known inflammatory process on screening or admission to each treatment period;
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
* Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion;
* Had donated or received any blood or blood products within the 3 months prior to screening;
* Vegetarians, vegans or have other medical dietary restrictions;
* Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;
* Unwilling or unable to give written informed consent;
* If female, was pregnant or breast-feeding;
* If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;
* Had received an investigational drug within 3 months of screening or was currently participating in another study.

Primary outcomes:
measure: Cmax (BIA 2-093) - the Maximum Plasma Concentration
timeFrame: Day 7 to 35
measure: Cmax (CBZ) - the Maximum Plasma Concentration
timeFrame: Day 28 to 35
measure: Cmax (CBZE) - the Maximum Plasma Concentration
timeFrame: Day 28 to 35
measure: AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093
timeFrame: Day 7 to 35
measure: AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ
timeFrame: Day 28 to 35
measure: AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE
timeFrame: Day 28 to 35
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: