Clinical trial NCT02283814: A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
Official title: A Phase-1, Open-label, Drug Interaction Study Between Eslicarbazepine Acetate 1200 mg and Topiramate 200 mg Following Multiple Dose Administrations in Healthy Male
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases

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 years 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; i f 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
* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker i s defined as someone who completely stopped smoking for at least 1 2 months before day 1 of this study

Exclusion Criteria:

* Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as wel l as severe hypersensitivity reactions (like angioedema) to any drugs
* Presence of significant gastrointestinal, l iver 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 o r kidney disease, o r surgery that may affect drug bioavailability, including but not limited to cholecystectomy
* Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic d isease
* Presence o f significant heart disease o r disorder according to ECG
* Presence or history of significant central nervous system disorder l ike convulsion or depression
* Presence o r history o f significant ocular disease
* Presence or history of severe hepatic impairment
* Presence or history of renal insufficiency (serum creatinine level greater than 135 μmol/L)
* History or presence of acidosis
* Use of valproic acid in the previous 7 days prior to Day 1 of the study.
* 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)
* Any clinically significant illness in the previous 28 days before day 1 of this study
* Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before Day 1 of this study
* Participation in another clinical trial or donation of 50 mL or more of blood in the previous 28 days before day 1 of this study
* Donation of 500 mL or more of blood (Canadian B lood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
* Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4).
* Positive results to HIV, HBsAg or anti-HCV tests

Primary outcomes:
measure: Cmax - the Maximum Plasma Concentration
timeFrame: 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
measure: Tmax - the Time of Occurrence of Cmax
timeFrame: 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 outcomes:
measure: AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: