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Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BIA 2-093

Moxifloxacin

Placebo

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Comprehensive Phase OneTM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Treatment Sequence ABCD

Treatment Sequence BDAC

Treatment Sequence CADB

Treatment Sequence DCBA

Arm Description

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

Outcomes

Primary Outcome Measures

QTcI - QT Interval Individually Corrected for Heart Rate - Day 5

Secondary Outcome Measures

QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula

QTcF - QT Interval Corrected Using Fridericia's Formula

Full Information

NCT ID

NCT02283788

First Posted

October 31, 2014

Last Updated

December 19, 2014

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02283788

Brief Title

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

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Sequence ABCD

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment Sequence BDAC

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment Sequence CADB

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment Sequence DCBA

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Other Intervention Name(s)

ESL, Eslicarbazepine acetate

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Other Intervention Name(s)

avalox

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

PLC

Primary Outcome Measure Information:

Title

QTcI - QT Interval Individually Corrected for Heart Rate - Day 5

Time Frame

-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose

Secondary Outcome Measure Information:

Title

QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula

Time Frame

-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose

Title

QTcF - QT Interval Corrected Using Fridericia's Formula

Time Frame

-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts 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.

Facility Information:

Facility Name

Comprehensive Phase OneTM

City

Miramar

State/Province

Florida

ZIP/Postal Code

33025

Country

United States

12. IPD Sharing Statement

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Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

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