Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Carbamazepine; Eslicarbazepine acetate

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.