Phase 1
N=67
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT02283788 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: QTcI - QT Interval Individually Corrected for Heart Rate - Day 5 — -8.05; -6.15; -2.77; -4.39 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BIA 2-093 (Drug); Moxifloxacin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY QTcI - QT Interval Individually Corrected for Heart Rate - Day 5 |
-8.05; -6.15; -2.77; -4.39; -9.34; -7.34 | — |
| SECONDARY QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula |
— | — |
| SECONDARY QTcF - QT Interval Corrected Using Fridericia's Formula |
— | — |
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
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 95 mmHg at screening or baseline.
- A resting ECG heart rate of 100 bpm.
Data sourced from ClinicalTrials.gov (NCT02283788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.