Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

NCT02283788 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-116
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (4)

Treatment Sequence ABCD

EXPERIMENTAL

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

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

Treatment Sequence BDAC

EXPERIMENTAL

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

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

Treatment Sequence CADB

EXPERIMENTAL

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

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

Treatment Sequence DCBA

EXPERIMENTAL

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

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

Interventions

BIA 2-093 DRUG

Also known as: ESL, Eslicarbazepine acetate

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Moxifloxacin DRUG

Also known as: avalox

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Placebo DRUG

Also known as: PLC

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Comprehensive Phase OneTM

Miramar, Florida, 33025, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Moxifloxacin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Head of Clinical Research
• Organization: BIAL - Portela & Cª, S.A.

francisco.rocha@bial.com

+351 22 9866100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: March 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 11, 2025
• Results First Posted: December 22, 2014

Record last verified: 2025-03

Locations

US (1)