Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

B

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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