Partial EpilepsyPhase 1NCT00898560
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
A Phase 1 study testing eslicarbazepine acetate and Microginon® and Microginon® in people with Partial Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- eslicarbazepine acetate and Microginon® and Microginon®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2008to Nov 2008
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal female subjects
- Age 18-40 years, inclusive
- Body mass index (BMI) 19-30 kg/m2, inclusive
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
- Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- Negative urine pregnancy test at screening and admission to each treatment period.
- Using one of the following methods of contraception: double barrier or intrauterine device
Who cannot join
- Subjects who have any contra-indication to the use of oral contraceptives
- History or presence of clinically relevant diseases, disorders or surgical history
- History of alcoholism or drug abuse
- Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado
Porto, 4745-457
About this study
Official title: Effect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
- Conditions
- Partial Epilepsy
- Being tested
- eslicarbazepine acetate and Microginon®, Microginon®
- Keywords
- Partial, Epilepsy, Eslicarbazepine acetate, Combined oral contraceptive, Pharmacokinetics, Tolerability
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eslicarbazepine acetate and Microginon®Drug
Also called ESL, BIA 2-093
eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
Microginon®Drug
Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
| Study group | Role | What they receive |
|---|---|---|
| Microginon® | Other | A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). Receives: Drug: Microginon® |
| ESL and Microginon® | Experimental | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. Receives: Drug: eslicarbazepine acetate and Microginon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Plasma Concentration
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Measured: 15-day
Secondary outcomes (2)
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Measured: 15-day
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Measured: 15-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
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 Partial 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Vaz-da-Silva, Principal investigator, Bial Portela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898560
- Sponsor's protocol ID
- BIA-2093-128
- Status last verified
- Dec 2014
- First submitted
- 11 May 2009
- Last updated
- 12 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00898560
- Acronym / sponsor ID
- BIA-2093-128
- Conditions
- Partial Epilepsy
- Keywords
- Partial, Epilepsy, Eslicarbazepine acetate, Combined oral contraceptive, Pharmacokinetics, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microginon® | Other | Drug: Microginon®A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). |
| ESL and Microginon® | Experimental | Drug: eslicarbazepine acetate and Microginon®15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pre-menopausal female subjects
- Age 18-40 years, inclusive
- Body mass index (BMI) 19-30 kg/m2, inclusive
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
- Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Key exclusion criteria (4 listed)
- Subjects who have any contra-indication to the use of oral contraceptives
- History or presence of clinically relevant diseases, disorders or surgical history
- History of alcoholism or drug abuse
- Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
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 acetate and Microginon®Also: ESL, BIA 2-093eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period | Drug | ESL and Microginon® |
| Microginon®Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel) | Drug | Microginon® |
Primary outcome
Cmax - Maximum Observed Plasma Concentration
Time frame: 15-day
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
2 secondary outcomes
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
Time frame: 15-day
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
Time frame: 15-day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- 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.
Manuel Vaz-da-Silva principal investigator
Bial Portela
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 Microginon® and Microginon® in people with Partial Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
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 7 inclusion and 4 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 12 Dec 2014. 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 Portugal. 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 12 Dec 2014). 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?
Cmax - Maximum Observed Plasma Concentration (time frame: 15-day). 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 12 Dec 2014.