Clinical trial NCT02283788: Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Official title: A Randomized, Double-blind, Placebo-controlled and Open Label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization in Healthy Adult Men and Women
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: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women

Detailed description: The purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected QT (QTcI) interval durations in adult healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Be a healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial and were required to have a negative pregnancy test at screening and upon each check-in to the study facility.
* Have a BMI within the range of 18-30 kg/m2.
* Be able to communicate effectively with the study personnel.
* Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on each admission to the clinic.
* Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
* Be nonsmokers defined as not having smoked in the past 6 months.
* Be adequately informed of the nature and risks of the study and give written informed consent prior to study entry.

Exclusion Criteria:

* Known hypersensitivity or allergy to moxifloxacin, eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
* Women who were pregnant or breast feeding.
* Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or placed the subject at increased risk.
* A sustained supine systolic blood pressure \> 140 mmHg or \<100mm Hg or a diastolic blood pressure \> 95 mmHg at screening or baseline.
* A resting ECG heart rate of \<50 bpm or \>100 bpm.

Primary outcomes:
measure: QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
timeFrame: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose
Secondary outcomes:
measure: QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula
timeFrame: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose
measure: QTcF - QT Interval Corrected Using Fridericia's Formula
timeFrame: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Phase OneTM
state: Florida
Study officials:
References: