Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult

Sponsor

Whanin Pharmaceutical Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04095182

Collaborator

(none)

Enrollment

Location

Arms

3.8

Actual Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Partial-onset Seizures With or Without Secondary Generalisation	Drug: Zebinix 400mg Drug: Placebo for Zebinix 400mg Drug: Zebinix 800mg Drug: Placebo for Zebinix 800mg Drug: Zebinix 1600mg Drug: Placebo for Zebinix 1600mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 22, 2019

Actual Primary Completion Date :

Dec 16, 2019

Actual Study Completion Date :

Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zebinix 400mg	Drug: Zebinix 400mg Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo Comparator: Placebo for Zebinix 400mg	Drug: Placebo for Zebinix 400mg Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Experimental: Zebinix 800mg	Drug: Zebinix 800mg Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo Comparator: Placebo for Zebinix 800mg	Drug: Placebo for Zebinix 800mg Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Experimental: Zebinix 1600mg	Drug: Zebinix 1600mg Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo Comparator: Placebo for Zebinix 1600mg	Drug: Placebo for Zebinix 1600mg Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)

Outcome Measures

Primary Outcome Measures

Time of maximum observed drug concentration (Tmax) ['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]
Maximum observed plasma drug concentration (Cmax) ['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]
Area under the plasma concentration time-curve (AUC) ['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]
Apparent terminal elimination half-life (t1/2) ['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]
Peak trough fluctuation (PTF) ['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]
Accumulation ratio (R) ['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]
Metabolic ratio ['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 Outcome Measures

Adverse event [Day -1 ~ Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Whan In Pharm.	Seoul		Korea, Republic of

Sponsors and Collaborators

Whanin Pharmaceutical Company

Investigators

Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Whanin Pharmaceutical Company

ClinicalTrials.gov Identifier:

NCT04095182

Other Study ID Numbers:

WID-ESL18-P1

First Posted:

Sep 19, 2019

Last Update Posted:

Jan 7, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Seizures

Eslicarbazepine acetate

Study Results

No Results Posted as of Jan 7, 2020