Status:
COMPLETED
A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose
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 eslicarbazepi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01879332
Start Date
December 1 2006
End Date
February 1 2007
Last Update
December 19 2014
Active Locations (1)
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1
Comprehensive Phase OneTM
Miramar, Florida, United States, 33025