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EpilepsyPhase 1NCT02284854

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

A Phase 1 study testing BIA 2-093 and Carbamazepine in people with Epilepsy, run by Bial - Portela C S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. 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 Carbamazepine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
Jul 2009to Nov 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 electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (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;
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  • Able and willing to give written informed consent;
  • If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
  • If female, had 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; have a clinically relevant surgical history;
  • History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives [e.g., carbamazepine, oxcarbazepine] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);
  • Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;
  • History of alcoholism or drug abuse;
  • Consumed more than 14 units1 of alcohol a week;
  • Significant infection or known inflammatory process on screening or admission to each treatment period;
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  • 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;
  • Had donated or received any blood or blood products within the 3 months prior to screening;
  • Vegetarians, vegans or have other medical dietary restrictions;
  • Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;
  • Unwilling or unable to give written informed consent;
  • If female, was pregnant or breast-feeding;
  • If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;
  • Had received an investigational drug within 3 months of screening or was currently participating in another study.

About this study

Official title: Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Read the detailed description

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Conditions
Epilepsy
Being tested
BIA 2-093, Carbamazepine
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 Eslicarbazepine acetate, ESL

  • CarbamazepineDrug

    Also called CBZ

Study groups in NCT02284854
Study groupRoleWhat they receive
Group AExperimentalDay 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Receives: Drug: BIA 2-093; Drug: Carbamazepine
Group BExperimentalDay 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Receives: Drug: BIA 2-093; Drug: Carbamazepine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax (BIA 2-093) - the Maximum Plasma Concentration

    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg

    Measured: Day 7 to 35

  2. Cmax (CBZ) - the Maximum Plasma Concentration

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

    Measured: Day 28 to 35

  3. Cmax (CBZE) - the Maximum Plasma Concentration

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily

    CBZE - carbamazepine-epoxide is the active metabolite of CBZ

    Measured: Day 28 to 35

  4. AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093

    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg

    Measured: Day 7 to 35

  5. AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

    Measured: Day 28 to 35

  6. AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE

    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg

    CBZE - carbamazepine-epoxide is the active metabolite of CBZ

    Measured: Day 28 to 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2014 (estimated)
  2. Study startJul 2009
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02284854
Sponsor's protocol ID
BIA-2093-129
Status last verified
Jan 2015
First submitted
4 Nov 2014
Last updated
8 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIA 2-093 and Carbamazepine 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 9 inclusion and 15 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 8 Jan 2015. 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 8 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 (BIA 2-093) - the Maximum Plasma Concentration (time frame: Day 7 to 35). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02284854.

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 8 Jan 2015.

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