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

NCT04095182 | Completed Phase 1

• 1 other identifier: WID-ESL18-P1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Partial-onset Seizures With or Without Secondary Generalisation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Adverse event

  Day -1 ~ Day 15

Study Arms (6)

Zebinix 400mg

EXPERIMENTAL

Drug: Zebinix 400mg

Placebo for Zebinix 400mg

PLACEBO COMPARATOR

Drug: Placebo for Zebinix 400mg

Zebinix 800mg

EXPERIMENTAL

Drug: Zebinix 800mg

Placebo for Zebinix 800mg

PLACEBO COMPARATOR

Drug: Placebo for Zebinix 800mg

Zebinix 1600mg

EXPERIMENTAL

Drug: Zebinix 1600mg

Placebo for Zebinix 1600mg

PLACEBO COMPARATOR

Drug: Placebo for Zebinix 1600mg

Interventions

Zebinix 400mg DRUG

Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Zebinix 400mg

Placebo for Zebinix 400mg DRUG

Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 400mg

Zebinix 800mg DRUG

Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Zebinix 800mg

Placebo for Zebinix 800mg DRUG

Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 800mg

Zebinix 1600mg DRUG

Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Zebinix 1600mg

Placebo for Zebinix 1600mg DRUG

Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 1600mg

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Whanin Pharmaceutical Company: lead

Study Sites (1)

Whan In Pharm.

Seoul, South Korea

Location

MeSH Terms

Interventions

eslicarbazepine acetate

Study Officials

• In-Jin Jang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 19, 2019
• Study Start: August 22, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

KR (1)