Clinical trial NCT04095182: Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
Official title: A Dose Randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of Zebinix (Eslicarbazepine Acetate) After Oral Administration in Healthy Korean and Caucasian Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Partial-onset Seizures With or Without Secondary Generalisation
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers aged 19-45 years at screening
* Subjects who weigh more than 50kg with a body mass index(BMI) of 18.0\~28.0 kg/m2 at screening
* Subjects who are fully understood after being given the detailed explanation of this clinical trial and willing to give written informed consent for participation prior to the screening test
* Subjects who are qualified to participate in this clinical trial through the physical examination, clinical laboratory test and interview by the investigators

Exclusion Criteria:

* Clinically significant presence or treatment history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, psychiatric
* Clinically significant surgical history
* Clinically significant family history
* Clinically significant atopic syndrome
* History of hypersensitivity or clinically significant hypersensitivity to drug including carbamazepine and related compounds
* History of alcoholism or drug abuse or show a positive response to an abuse drug in the urine drug screening test
* Consistently consume alcohol or cannot stop drinking during the clinical trial
* Smoker
* Significant infection or inflammatory finding at screening visit
* History of gastrointestinal disorders or surgery which may have an effect on the safety and pharmacokinetic evaluation of the investigational products (except for simple appendectomy and herniotomy)
* Have used prescription drugs or herbal medication within 2 weeks of initial administration or who have used over the counter(OTC), health functional food or vitamins within 1 week of initial administration (but, if the other conditions are suitable according to the judgment of the investigator, they can participate in the clinical trial), or subjects who have expected to take it
* Have participated in any clinical trial (or bioequivalence study) and administered any investigational product within 6 months
* Positive for HbsAg, anti-HCV and HIV antigen-antibody reaction tests at screening
* Have donated any whole blood or apheresis or received blood transfusion within 3 months of initial administration of this clinical trial
* Have dietary restrictions or cannot take the food provided by the institution
* Cannot communicate reliably with the investigator
* Subjects who are determined by the investigator to be ineligible for participation in this clinical trial due to clinical laboratory test results or other reasons

Primary outcomes:
measure: Time of maximum observed drug concentration (Tmax)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Area under the plasma concentration time-curve (AUC)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Peak trough fluctuation (PTF)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Accumulation ratio (R)
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
measure: Metabolic ratio
timeFrame: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Secondary outcomes:
measure: Adverse event
timeFrame: Day -1 ~ Day 15
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Whan In Pharm.
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: