Trials / Completed
CompletedNCT04903314
Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- SK Life Science, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.
Detailed description
The secondary objective of this study is to evaluate the safety and tolerability of cenobamate (YKP3089) following single and multiple dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xcopri | Xcopri will be administered orally not to exceed 400mg/day adult equivalent |
Timeline
- Start date
- 2021-05-27
- Primary completion
- 2025-11-06
- Completion
- 2025-11-06
- First posted
- 2021-05-26
- Last updated
- 2026-03-31
Locations
13 sites across 3 countries: United States, Hungary, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04903314. Inclusion in this directory is not an endorsement.