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

NCT01879332 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-118
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

Anticonvulsant

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events Reported

  Safety was evaluated through the recording and monitoring of adverse events

  2 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching placebo tablets for oral administration

Drug: Placebo

BIA 2-093 3000 mg once daily

EXPERIMENTAL

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

BIA 2-093 3600 mg once daily

EXPERIMENTAL

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

Interventions

Placebo DRUG

Matching placebo tablets for oral administration

Also known as: sugar pills

Placebo

BIA 2-093 3000 mg once daily DRUG

Eslicarbazepine acetate 600 mg tablets for oral administration

Also known as: eslicarbazepine acetate

BIA 2-093 3000 mg once daily

BIA 2-093 3600 mg once daily DRUG

Eslicarbazepine acetate 600 mg tablets for oral administration

Also known as: Eslicarbazepine acetate

BIA 2-093 3600 mg once daily

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

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

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 17, 2013
• Study Start: December 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (1)