Partial-onset Seizures With or Without Secondary GeneralisationPhase 1NCT04095182
Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
A Phase 1 study testing Zebinix 400mg, Zebinix 800mg and Zebinix 1600mg in people with Partial-onset Seizures With or Without Secondary Generalisation, run by Whanin Pharmaceutical Company at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial-onset Seizures With or Without Secondary Generalisation
- What is being tested?
- Zebinix 400mg, Zebinix 800mg and Zebinix 1600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2019to 16 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Zebinix 400mg, Placebo for Zebinix 400mg, Zebinix 800mg, Placebo for Zebinix 800mg, Zebinix 1600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zebinix 400mgDrug
Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo for Zebinix 400mgDrug
Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Zebinix 800mgDrug
Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo for Zebinix 800mgDrug
Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Zebinix 1600mgDrug
Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Placebo for Zebinix 1600mgDrug
Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
| Study group | Role | What they receive |
|---|---|---|
| Zebinix 400mg | Experimental | Not described Receives: Drug: Zebinix 400mg |
| Placebo for Zebinix 400mg | Placebo comparator | Not described Receives: Drug: Placebo for Zebinix 400mg |
| Zebinix 800mg | Experimental | Not described Receives: Drug: Zebinix 800mg |
| Placebo for Zebinix 800mg | Placebo comparator | Not described Receives: Drug: Placebo for Zebinix 800mg |
| Zebinix 1600mg | Experimental | Not described Receives: Drug: Zebinix 1600mg |
| Placebo for Zebinix 1600mg | Placebo comparator | Not described Receives: Drug: Placebo for Zebinix 1600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of maximum observed drug concentration (Tmax)
Measured: '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)
Measured: '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)
Measured: '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)
Measured: '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)
Measured: '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)
Measured: '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
Measured: '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
Measured: Day -1 ~ Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start22 Aug 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-onset Seizures With or Without Secondary GeneralisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Whanin Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095182
- Sponsor's protocol ID
- WID-ESL18-P1
- Status last verified
- Jan 2020
- First submitted
- 15 Sep 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095182
- Acronym / sponsor ID
- WID-ESL18-P1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Whanin Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zebinix 400mgZebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Zebinix 400mg |
| Placebo for Zebinix 400mgPlacebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Placebo for Zebinix 400mg |
| Zebinix 800mgZebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Zebinix 800mg |
| Placebo for Zebinix 800mgPlacebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Placebo for Zebinix 800mg |
| Zebinix 1600mgZebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Zebinix 1600mg |
| Placebo for Zebinix 1600mgPlacebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11) | Drug | Placebo for Zebinix 1600mg |
Primary outcome
Time of maximum observed drug concentration (Tmax)
Time frame: '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)
Time frame: '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)
Time frame: '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)
Time frame: '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)
Time frame: '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)
Time frame: '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
Time frame: '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
1 secondary outcome
Adverse event
Time frame: Day -1 ~ Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zebinix 400mg, Zebinix 800mg and Zebinix 1600mg in people with Partial-onset Seizures With or Without Secondary Generalisation, run by Whanin Pharmaceutical Company at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of maximum observed drug concentration (Tmax) (time frame: '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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.