Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283788
• Other study ID #: BIA-2093-116
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2014
• Last updated: December 19, 2014
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093

• Moxifloxacin

• Placebo

Locations

Country	Name	City	State
United States	Comprehensive Phase OneTM	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTcI - QT Interval Individually Corrected for Heart Rate - Day 5		-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose	No
Secondary	QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula		-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose	No
Secondary	QTcF - QT Interval Corrected Using Fridericia's Formula		-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose	No