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Anti-epileptic drug

Treatment A (Reference) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by SK Life Science, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 days
Awards & highlights

Study Summary

This trial is testing the relative bioavailability of a crushed 200 mg cenobamate tablet vs. an intact (whole) 200 mg tablet vs. a crushed 200 mg tablet via NG tube.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUCinf (AUC0-inf)
AUClast
Cmax
Secondary outcome measures
Safety and Tolerability - Adverse Events
Safety and Tolerability - Clinical Laboratory Tests
Safety and Tolerability - Columbia Suicide Severity Rating Scale
+3 more

Side effects data

From 2021 Phase 2 trial • 222 Patients • NCT01397968
22%
Somnolence
22%
Dizziness
12%
Nausea
12%
Headache
11%
Fatigue
10%
Nystagmus
8%
Balance disorder
8%
Urinary tract infection
7%
Upper respiratory tract infection
6%
Tremor
6%
Nasopharyngitis
5%
Vomiting
5%
Diarrhea
5%
Constipation
1%
Status epilepticus
1%
Anxiety
1%
Drug hypersensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment C (Test 2)Experimental Treatment1 Intervention
A crushed 200 mg cenobamate tablet in suspension administered via an NG tube
Group II: Treatment B (Test 1)Experimental Treatment1 Intervention
A crushed 200 mg cenobamate tablet in suspension administrated orally.
Group III: Treatment A (Reference)Experimental Treatment1 Intervention
An intact 200 mg cenobamate tablet administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenobamate
2020
Completed Phase 1
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,823 Total Patients Enrolled
Vijaykumar VashiStudy DirectorSKLSI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks accompany the administration of Treatment C (Test 2)?

"Our team at Power has assessed the safety of Treatment C (Test 2) to be a mere 1 out of 3 due to the limited clinical data concerning its efficacy and security."

Answered by AI

To which demographic is eligibility for this trial extended?

"This clinical trial is actively enrolling 24 individuals aged 18 to 50 who can demonstrate good health. Criteria for potential participants include the following: Male or female subjects of 18 to 50 years old (inclusively), literacy in order to read, understand and sign an informed consent form, BMI between 18.5-30.0 kg/m2, normal electrocardiogram results, blood pressure and heart rate readings., compliance with study protocols and ability to complete the trial as planned by investigators; females must have undergone a surgical sterilization procedure at least 6 months prior dosing or be postmenopausal with amenorrhea for 1 year before"

Answered by AI

Is this research program currently open for recruitment?

"Affirmative. Published records on clinicaltrials.gov confirm that this research project, which originally went public on September 27th 2022, is actively recruiting participants. 24 individuals must be sourced from 1 medical site in order to complete the trial's requirements."

Answered by AI

What is the aggregate count of participants in this medical trial?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial has openings for 24 participants, which was initially posted on September 27th 2022 and last updated October 6th 2022 at a single site."

Answered by AI

What results are researchers expecting to glean from this investigation?

"SK Life Science, Inc., the study sponsor, has outlined that Cmax is the primary objective to be measured over a span of 38 days. Additionally, they will also assess safety and tolerability through vitals signs such as systolic and diastolic blood pressure readings, pulse rate measurements, respiration rates, body temperature checks and Columbia Suicide Severity Rating Scale scores. Lastly, adverse events (AEs) are another secondary outcome being tracked for this trial."

Answered by AI

Does this research initiative encompass individuals who are younger than 65 years of age?

"This experiment adheres to the inclusion criteria of 18 as a minimum age and 50 as a maximum age for participation."

Answered by AI
~10 spots leftby Apr 2025