Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.

November 3, 2014 updated by: Bial - Portela C S.A.

A Phase 1, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Lamotrigine 150mg Following Multiple Doses Administrations in Healthy Male Volunteers

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Lamotrigine (LMT) in last phases; Group B: Pre-treatment with LMT, treatment with LMT and ascending doses of ESL in last phases

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
  • Male aged of at least 18 years but not older than 45 rears with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
  • Healthy according to the medical history, laboratory results and physical examination
  • Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day I of thi s study The informed consent form must be signed by all volunteers, prior to their participation in the study.

Exclusion Criteria:

  • Significant history of hypersensitivity to lamotrigine, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
  • History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
  • Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of significant heart disease or disorder according to ECG
  • Presence or history of significant central nervous system disorder like convulsion or depression
  • Presence or history of significant ocular disease
  • Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

Group A

  • Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
  • Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
  • Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 50 mg for two consecutive days
  • Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg for seventeen consecutive days
Drug: Lamotrigine
Other Names:
  • LMT
Drug: Eslicarbazepine acetate
Other Names:
  • ESL
Experimental: Group B

Group B

  • Pre-treatment: 50 mg once daily dose of lamotrige (LMT) administered for two consecutive days;
  • Treatment: 150 mg once daily dose of lamotrige (LMT) administered for six consecutive days;
  • Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1600 mg and lamotrigine 150 mg for two consecutive days
  • Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg for seventeen consecutive days
Drug: Lamotrigine
Other Names:
  • LMT
Drug: Eslicarbazepine acetate
Other Names:
  • ESL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax - the maximum plasma concentration
Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h

Secondary Outcome Measures

Outcome Measure
Time Frame
tmax - the time of occurrence of Cmax
Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial - Portela C S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-2093-119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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