EpilepsyPhase 1NCT00987558
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
A Phase 1 study testing Eslicarbazepine acetate and Simvastatin in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Eslicarbazepine acetate and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Epilepsy
- Being tested
- Eslicarbazepine acetate, Simvastatin
- Keywords
- Eslicarbazepine acetate, simvastatin
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetateDrug
Also called Zebinix
SimvastatinDrug
Also called Zocor
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A | Experimental | Simvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period Receives: Drug: Eslicarbazepine acetate; Drug: Simvastatin |
| Treatment Sequence B | Experimental | Simvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period Receives: Drug: Eslicarbazepine acetate; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simvastatin Cmax (Maximum Plasma Concentration)
Simvastatin (Reference) ESL + Simvastatin (Test)
Measured: Day 1 and Day 14
Simvastatin Tmax (Time of Occurrence of Cmax)
Simvastatin (Reference) ESL + Simvastatin (Test)
Measured: 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)
Measured: Day 1 and Day 14
Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)
Simvastatin (Reference) ESL + Simvastatin (Test)
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie Claude Homery, MD, Principal investigator, Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987558
- Sponsor's protocol ID
- BIA-2093-124
- Status last verified
- Jan 2015
- First submitted
- 30 Sep 2009
- Last updated
- 13 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00987558
- Acronym / sponsor ID
- BIA-2093-124
- Conditions
- Epilepsy
- Keywords
- Eslicarbazepine acetate, simvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Posted 13 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A | Experimental | Drug: Eslicarbazepine acetate, Drug: SimvastatinSimvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period |
| Treatment Sequence B | Experimental | Drug: Eslicarbazepine acetate, Drug: SimvastatinSimvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eslicarbazepine acetateAlso: Zebinix | Drug | Treatment Sequence A, Treatment Sequence B |
| SimvastatinAlso: Zocor | Drug | Treatment Sequence A, Treatment Sequence B |
Primary outcome
Simvastatin Cmax (Maximum Plasma Concentration)
Time frame: Day 1 and Day 14
Simvastatin (Reference) ESL + Simvastatin (Test)
Simvastatin Tmax (Time of Occurrence of Cmax)
Time frame: Day 1 and Day 14
Simvastatin (Reference) ESL + Simvastatin (Test)
Simvastatin AUC0-t
Time frame: Day 1 and Day 14
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)
Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)
Time frame: Day 1 and Day 14
Simvastatin (Reference) ESL + Simvastatin (Test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Claude Homery, MD principal investigator
Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eslicarbazepine acetate and Simvastatin in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simvastatin Cmax (Maximum Plasma Concentration) (time frame: Day 1 and Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.