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A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01879332
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Placebo Drug: BIA 2-093 3000 mg once daily Drug: BIA 2-093 3600 mg once daily Phase 1

Detailed Description:

This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days.

A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
Study Start Date : December 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo tablets for oral administration
Drug: Placebo
Matching placebo tablets for oral administration
Other Name: sugar pills

Experimental: BIA 2-093 3000 mg once daily
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
Drug: BIA 2-093 3000 mg once daily
Eslicarbazepine acetate 600 mg tablets for oral administration
Other Name: eslicarbazepine acetate

Experimental: BIA 2-093 3600 mg once daily
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
Drug: BIA 2-093 3600 mg once daily
Eslicarbazepine acetate 600 mg tablets for oral administration
Other Name: Eslicarbazepine acetate




Primary Outcome Measures :
  1. Number of Adverse Events Reported [ Time Frame: 2 days ]
    Safety was evaluated through the recording and monitoring of adverse events



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:

  • 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. Female subjects were required to have a negative pregnancy test at screening and upon check-in to the study facility.
  • BMI within the range of 18-30 kg/m2.
  • Ability to communicate effectively with the study personnel.
  • No significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic.
  • Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
  • Nonsmokers defined as not having smoked in the past 6 months.
  • Subjects were to be adequately informed of the nature and risks of the study and were required to provide written informed consent prior to study entry.

Exclusion Criteria:

  • Known hypersensitivity or allergy to 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, had the potential to compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that could interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
  • A sustained supine systolic blood pressure > 140 mmHg or <100mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline.
  • A resting ECG heart rate of <50 bpm or >100 bpm.
  • An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (msec), QTc (Fridericia correction) > 450 msec, PR interval > 240 msec. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant.
  • The presence of abnormal laboratory values which were considered clinically significant.
  • Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1 or 2).
  • Receipt of an investigational drug within a period of 30 days prior to enrollment in the study.
  • Receipt of any drug therapy, including hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
  • Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
  • A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
  • Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
  • A history of difficulty with donating blood.
  • Donation of blood or blood products within 45 days prior to enrollment.
  • Subjects with, or with a history of, additional risk factors for Torsades de Points (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.

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): NCT01879332


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: NCT01879332    
Other Study ID Numbers: BIA-2093-118
First Posted: June 17, 2013    Key Record Dates
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Anticonvulsant
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action