Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.

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

Details

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

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 ECG; negative tests for HBsAg, anti-HCVAb and 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 uses one of the following methods of contraception: double barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);

• If female, has 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

• Clinically relevant surgical history;

• History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins or any of its excipients

• History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain

• Second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator

• History of alcoholism or drug abuse

• Consume more than 14 units 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

• Have donated or received any blood or blood products within the 3 months prior to screening

• Vegetarians, vegans or have other medical dietary restrictions

• Cannot communicate reliably with the investigator

• Unlikely to co-operate with the requirements of the study

• Unwilling or unable to give written informed consent

• If female, is pregnant or breast-feeding

• If female, is of childbearing potential and does not use an approved effective contraceptive method (double-barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses hormonal contraceptives

• Have received an investigational drug within 3 months of screening or is currently participating in another study