Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

NCT ID: NCT02283788

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-06-30

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Sequence ABCD

A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Treatment Sequence BDAC

A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Treatment Sequence CADB

A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Treatment Sequence DCBA

A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

BIA 2-093

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

ESL, Eslicarbazepine acetate; avalox; PLC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Comprehensive Phase OneTM

Miramar, Florida, United States

Countries

United States

Other Identifiers

BIA-2093-116

Identifier Type: -

Identifier Source: org_study_id