Status:
COMPLETED
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 m...
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 esl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT02283788
Start Date
March 1 2007
End Date
June 1 2007
Last Update
April 11 2025
Active Locations (1)
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1
Comprehensive Phase OneTM
Miramar, Florida, United States, 33025