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
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 April 17, 2014