Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

BIAL

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: Moxifloxacin; Drug: Placebo; Drug: BIA 2-093

Study type: Interventional

Funder types: Industry

Identifiers

NCT02283788

BIA-2093-116

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 4 patient groups

Treatment Sequence ABCD

Experimental group

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

Treatment:

Drug: BIA 2-093

Drug: Placebo

Drug: Moxifloxacin

Treatment Sequence BDAC

Experimental group

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

Treatment:

Drug: BIA 2-093

Drug: Placebo

Drug: Moxifloxacin

Treatment Sequence CADB

Experimental group

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

Treatment:

Drug: BIA 2-093

Drug: Placebo

Drug: Moxifloxacin

Treatment Sequence DCBA

Experimental group

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

Treatment:

Drug: BIA 2-093

Drug: Placebo

Drug: Moxifloxacin