Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

• ClinicalTrials.gov Identifier: NCT02283788
• Recruitment Status: Completed
• First Posted: November 5, 2014
• Results First Posted: December 22, 2014
• Last Update Posted: December 22, 2014
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

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

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: BIA 2-093; Drug: Moxifloxacin; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2007
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate; Drug: Moxifloxacin; Other Name: avalox; Drug: Placebo; Other Name: PLC
Experimental: 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	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate; Drug: Moxifloxacin; Other Name: avalox; Drug: Placebo; Other Name: PLC
Experimental: 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	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate; Drug: Moxifloxacin; Other Name: avalox; Drug: Placebo; Other Name: PLC
Experimental: 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	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate; Drug: Moxifloxacin; Other Name: avalox; Drug: Placebo; Other Name: PLC

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Comprehensive Phase OneTM

Miramar, Florida, United States, 33025

Sponsors and Collaborators

Bial - Portela C S.A.

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT02283788
• Other Study ID Numbers: BIA-2093-116
• First Posted: November 5, 2014
• Results First Posted: December 22, 2014
• Last Update Posted: December 22, 2014
• Last Verified: December 2014

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Moxifloxacin; Eslicarbazepine acetate; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators