EpilepsyPhase 1NCT02287415
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
A Phase 1 study testing BIA 2-093 and Warfarin in people with Epilepsy, run by Bial - Portela C S.A..
Trial summary
Multiple-dose, open-label, single-period study consisting of three consecutive phases 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 Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jul 2002
- 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, neurological examination, and 12-lead ECG
- Subjects who had clinical laboratory tests clinically acceptable
- Subjects who were negative for HBs Ag, anti-HCV Ab and anti-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 smoked less than 10 cigarettes or equivalent per day
- Subjects who were able and willing to give written informed consent
- In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device
- In case of female volunteers, subjects who had a negative pregnancy test at screening
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 current haemostatic disorder or a personal or family history of any such disorder
- Subjects who had a personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
- Subjects with a profession or activities implying a special risk of trauma
- Subjects with any abnormality in the coagulation status (aPTT or prothrombin INR)
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- 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 relevant drug hypersensitivity
- 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 admission
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn)
- Subjects who had used prescription drugs within 2 weeks prior admission on Phase A
- Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months prior admission to Phase A
- Subjects who had previously received BIA 2-093
- Subjects who had donated and/or received any blood or blood products within the previous 2 months prior admission to Phase A
- Subjects who were vegetarians, vegans and/or had medical dietary restrictions
- Subjects who could not communicate reliably with the investigator
About this study
Official title: The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Multiple-dose, open-label, single-period study consisting of three consecutive phases
Read the detailed description
Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses
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
WarfarinDrug
Also called Uniwarfin
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin Receives: Drug: BIA 2-093; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Steady-state Plasma Concentration
Measured: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Secondary outcomes (2)
Tmax - Time of Occurrence of Cmax
Measured: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval
Measured: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startMay 2002
- Primary completionJul 2002
- Study completionJul 2002
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02287415
- Sponsor's protocol ID
- BIA-2093-108
- Status last verified
- Nov 2014
- First submitted
- 6 Nov 2014
- Last updated
- 1 Dec 2014
- 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 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02287415
- Acronym / sponsor ID
- BIA-2093-108
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple-dose, open-label, single-period study consisting of three consecutive phases
Detailed description
Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BIA 2-093, Drug: WarfarinPhase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin |
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, neurological examination, and 12-lead ECG
- Subjects who had clinical laboratory tests clinically acceptable
- Subjects who were negative for HBs Ag, anti-HCV Ab and anti-HIV-1 and HIV-2 Ab tests at screening
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 current haemostatic disorder or a personal or family history of any such disorder
- Subjects who had a personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
- Subjects with a profession or activities implying a special risk of trauma
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 1 |
| WarfarinAlso: Uniwarfin | Drug | Group 1 |
Primary outcome
Cmax - Maximum Steady-state Plasma Concentration
Time frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
2 secondary outcomes
Tmax - Time of Occurrence of Cmax
Time frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval
Time frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIA 2-093 and Warfarin in people with Epilepsy, run by Bial - Portela C S.A..
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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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 Steady-state Plasma Concentration (time frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin 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 1 Dec 2014.