EpilepsyPhase 1NCT02279667
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
A Phase 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- Feb 2004to Mar 2004
- 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 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, vital signs and 12-lead ECG at screening.
- Subjects who had clinical laboratory tests clinically acceptable at screening.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- Subjects who were negative for alcohol and drugs of abuse at screening.
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- Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
- (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: doublebarrier, intra-uterine device or abstinence.
- (If female) She had a negative pregnancy test at screening and admission to each study period.
Who cannot join
- Subjects who do not conform to the above inclusion criteria, or
- Subjects who have 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 have a clinically relevant surgical history.
- Subjects who have a clinically relevant family history.
- Subjects who have a history of relevant atopy.
- Subjects who have a history of any drug hypersensitivity.
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- Subjects who have a history of alcoholism or drug abuse.
- Subjects who consume more than 14 units of alcohol a week.
- Subjects who have a significant infection or known inflammatory process on screening and/or first admission.
- Subjects who have acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who have used medicines within 2 weeks of admission to first period.
- Subjects who have participated in any clinical trial within 3 months prior to screening.
- Subjects who have previously received BIA 2-093.
- Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to screening.
- Subjects who are vegetarians, vegans and/or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigation team.
- Subjects who are unlikely to co-operate with the requirements of the study.
- Subjects who are unwilling or unable to give written informed consent.
- (If female) She is pregnant or breast-feeding.
- (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CEB - Centre for Bioavailability Studies, AIBILI
Azinhaga de Santa Comba - Celas, Coimbra District
About this study
Official title: Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.
Read the detailed description
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.
Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.
- Conditions
- Epilepsy
- Being tested
- 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
oral suspension 50 mg/mL
BIA 2-093Drug
Also called ESL, Eslicarbazepine acetate
200 mg tablet
BIA 2-093Drug
Also called ESL, Eslicarbazepine acetate
800 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 1. st period - 16 mL oral suspension 50 mg/mL
2. nd period - Four 200 mg tablets
3. rd period - One 800 mg tablet Receives: Drug: BIA 2-093 |
| Group B | Experimental | 1. st period - One 800 mg tablet
2. nd period - 16 mL oral suspension 50 mg/mL
3. rd period - Four 200 mg tablets Receives: Drug: BIA 2-093 |
| Group C | Experimental | 1. st period - Four 200 mg tablets
2. nd period - One 800 mg tablet
3. rd period - 16 mL oral suspension 50 mg/mL Receives: Drug: BIA 2-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - the Maximum Plasma Concentration
Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Measured: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the Time of Occurrence of Cmax
Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Measured: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005
Measured: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005
Measured: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startFeb 2004
- Primary completionMar 2004
- Study completionMar 2004
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279667
- Sponsor's protocol ID
- BIA-2093-109
- Status last verified
- Dec 2014
- First submitted
- 29 Oct 2014
- Last updated
- 1 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 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02279667
- Acronym / sponsor ID
- BIA-2093-109
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 31 Oct 2014 (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.
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.
Detailed description
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.
Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.
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 2-0931. st period - 16 mL oral suspension 50 mg/mL 2. nd period - Four 200 mg tablets 3. rd period - One 800 mg tablet |
| Group B | Experimental | Drug: BIA 2-0931. st period - One 800 mg tablet 2. nd period - 16 mL oral suspension 50 mg/mL 3. rd period - Four 200 mg tablets |
| Group C | Experimental | Drug: BIA 2-0931. st period - Four 200 mg tablets 2. nd period - One 800 mg tablet 3. rd period - 16 mL oral suspension 50 mg/mL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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, vital signs and 12-lead ECG at screening.
- Subjects who had clinical laboratory tests clinically acceptable at screening.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
Key exclusion criteria (20 listed)
- Subjects who do not conform to the above inclusion criteria, or
- Subjects who have 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 have a clinically relevant surgical history.
- Subjects who have a clinically relevant family history.
- Subjects who have 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 acetateoral suspension 50 mg/mL | Drug | Group A, Group B, Group C |
| BIA 2-093Also: ESL, Eslicarbazepine acetate200 mg tablet | Drug | Group A, Group B, Group C |
| BIA 2-093Also: ESL, Eslicarbazepine acetate800 mg tablet | Drug | Group A, Group B, Group C |
Primary outcome
Cmax - the Maximum Plasma Concentration
Time frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Tmax - the Time of Occurrence of Cmax
Time frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
Time frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
Time frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 10 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 1 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 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 - the Maximum Plasma Concentration (time frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose). 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 1 Jan 2015.