EpilepsyPhase 1NCT01679002
Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
A Phase 1 study testing BIA 2-093 and Oxcarbazepine in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects. 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?
- BIA 2-093 and Oxcarbazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2003to Dec 2003
- 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
- Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests clinically acceptable.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
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- Subjects who were negative for alcohol and drugs of abuse at screening and first admission.
- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
- If case of female subjects, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, who used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
- If case of female subjects, subjects who had a negative pregnancy test at screening and first admission.
Who cannot join
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a 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.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of hypersensitivity to carbamazepine or oxcarbazepine or any other relevant drug hypersensitivity.
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- Subjects who had a history of alcoholism or drug abuse.
- Subjects who consumed more than 14 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening and/or first admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used prescription or over-the-counter medication within two weeks of first admission.
- Subjects who had used any investigational drug and/or participated in any clinical trial within four months of their first admission.
- Subjects who had previously received BIA 2-093.
- Subjects who had donated and/or received any blood or blood products within the previous 4 months prior to screening.
- Subjects who were vegetarians, vegans and/or have medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
- In case of female subjects, subjects who were pregnant or breast-feeding.
- In case of female subjects, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
BIAL - Portela & Cª S.A. - Human Pharmacology Unit (UFH)
S. Mamede Do Coronado, Trofa, 4745-457
About this study
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.
Read the detailed description
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.
- Conditions
- Epilepsy
- Being tested
- BIA 2-093, Oxcarbazepine
- Keywords
- Epilepsy, Oxcarbazepine, Eslicarbazepine Acetate, BIA 2-093
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 2-093Drug
Also called ESL, Eslicarbazepine acetate
OxcarbazepineDrug
Also called OXC, Trileptal®
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period
BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid Receives: Drug: BIA 2-093; Drug: Oxcarbazepine |
| Group B | Experimental | BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od Receives: Drug: BIA 2-093; Drug: Oxcarbazepine |
| Group C | Experimental | oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period
OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid Receives: Drug: BIA 2-093; Drug: Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Plasma Drug Concentration
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:
BIA 2-194 BIA 2-195 Oxcarbazepine
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Secondary outcomes (2)
AUC - Area Under the Plasma Concentration Versus Time Curve
AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:
BIA 2-194 BIA 2-195 Oxcarbazepine
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Number of of Subjects Reporting at Least One Adverse Event
Number of of subjects reporting at least one adverse event.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startOct 2003
- Primary completionDec 2003
- Study completionDec 2003
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
- 12 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, MD, PhD, Principal investigator, BIAL - Portela & Cª S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679002
- Sponsor's protocol ID
- BIA-2093-110
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2012
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01679002
- Acronym / sponsor ID
- BIA-2093-110
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Oxcarbazepine, Eslicarbazepine Acetate, BIA 2-093
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.
Detailed description
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BIA 2-093, Drug: OxcarbazepineBIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid |
| Group B | Experimental | Drug: BIA 2-093, Drug: OxcarbazepineBIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od |
| Group C | Experimental | Drug: BIA 2-093, Drug: Oxcarbazepineoxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests clinically acceptable.
Key exclusion criteria (20 listed)
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a 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.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
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 |
|---|---|---|
| BIA 2-093Also: ESL, Eslicarbazepine acetate | Drug | Group A, Group B, Group C |
| OxcarbazepineAlso: OXC, Trileptal® | Drug | Group A, Group B, Group C |
Primary outcome
Cmax - Maximum Observed Plasma Drug Concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
2 secondary outcomes
AUC - Area Under the Plasma Concentration Versus Time Curve
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Number of of Subjects Reporting at Least One Adverse Event
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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, MD, PhD principal investigator
BIAL - Portela & Cª S.A.
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 BIA 2-093 and Oxcarbazepine in people with 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 11 inclusion and 20 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 6 Apr 2025. 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 1 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?
Cmax - Maximum Observed Plasma Drug Concentration (time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose). 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 6 Apr 2025.