Back to resultsOpen-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Eslicarbazepine acetate
Lamotrigine
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
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
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
Outcomes
Primary Outcome Measures
Cmax - the maximum plasma concentration
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
Secondary Outcome Measures
tmax - the time of occurrence of Cmax
Full Information
NCT ID
NCT02283801
First Posted
November 3, 2014
Last Updated
November 3, 2014
Sponsor
Bial - Portela C S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02283801
Brief Title
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.
Official Title
A Phase 1, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Lamotrigine 150mg Following Multiple Doses Administrations in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
ESL
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
LMT
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
12. IPD Sharing Statement
Learn more about this trial
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.
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