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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00987558
First received: September 30, 2009
Last updated: March 29, 2012
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Simvastatin + ESL
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL) 800 mg once-daily affects the pharmacokinetics of simvastatin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the tolerability of concomitant administration of ESL 800 mg and simvastatin [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eslicarbazepine acetate + simvastatin
Simvastatin 80 mg + eslicarbazepine acetate 800 mg
Drug: Simvastatin + ESL
Oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─, separated by a washout period of 3 weeks or more
Other Names:
  • Zebinix
  • Exalief

Detailed Description:

This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─, separated by a washout period of 3 weeks or more

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987558

Locations
France
Biotrial, 7-9 rue Jean-Louis Bertrand
Rennes, France, F-35000
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Marie Claude Homery, MD Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00987558     History of Changes
Other Study ID Numbers: BIA-2093-124
Study First Received: September 30, 2009
Last Updated: March 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine acetate
simvastatin

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014