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

NCT00987558 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-124
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

Eslicarbazepine acetate; simvastatin

Outcome Measures

Primary Outcomes (4)

• Simvastatin Cmax (Maximum Plasma Concentration)

  Simvastatin (Reference) ESL + Simvastatin (Test)

  Day 1 and Day 14

• Simvastatin Tmax (Time of Occurrence of Cmax)

  Simvastatin (Reference) ESL + Simvastatin (Test)

  Day 1 and Day 14

• Simvastatin AUC0-t

  AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification Simvastatin (Reference) ESL + Simvastatin (Test)

  Day 1 and Day 14

• Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)

  Simvastatin (Reference) ESL + Simvastatin (Test)

  Day 1 and Day 14

Study Arms (2)

Treatment Sequence A

EXPERIMENTAL

Simvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period

Drug: Eslicarbazepine acetate; Drug: Simvastatin

Treatment Sequence B

EXPERIMENTAL

Simvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period

Drug: Eslicarbazepine acetate; Drug: Simvastatin

Interventions

Eslicarbazepine acetate DRUG

Also known as: Zebinix

Treatment Sequence A; Treatment Sequence B

Simvastatin DRUG

Also known as: Zocor

Treatment Sequence A; Treatment Sequence B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Biotrial, 7-9 rue Jean-Louis Bertrand

Rennes, F-35000, France

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Simvastatin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

Study Officials

• Marie Claude Homery, MD

  Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 13, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-01

Locations

FR (1)