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Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283788


Locations
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United States, Florida
Comprehensive Phase OneTM
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02283788    
Other Study ID Numbers: BIA-2093-116
First Posted: November 5, 2014    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Moxifloxacin
Eslicarbazepine acetate
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators