??? ??? ?? CENOBAMATE (YKP3089) ??? 1? ????

A SINGLE-CENTER, PHASE 1, ORAL ADMINISTRATION, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE ASCENDING DOSE STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF CENOBAMATE (YKP3089) IN HEALTHY JAPANESE SUBJECTS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002880

Enrollment

Registered

2018-05-18

Start date

2018-02-27

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Up to 4 groups of 8 subjects (6 actives and 2 placebos) will be studied and will receive either a single oral dose of 50, 100, 200 and 400 mg of Cenobamate or placebo dose, with a minimal 7-day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male or female Japanese subjectsd between 19 and 50 years of age

Exclusion criteria

Exclusion criteria: History or evidence of clinically significant gastrointestinal, renal, hepatic, respiratory, cardiovascular, endocrine, metabolic, immunologic, hematologic, muscular, neurological or psychiatric disease or disorder

Design outcomes

Primary

Measure	Time frame
Cmax, tmax, AUC0-last, AUCinf, AUC0-last/AUCinf, t1/2, CL/F, kel, and Vd/F	—

Secondary

Measure	Time frame
Columbia Suicide Severity Rating Scale (C-SSRS);Concomitant medications;Adverse events (AEs);vital signs;ECG parameters;clinical laboratory evaluations;physical examination findings;sedation tests;neurologic examinations	—

Countries

Korea, Republic of

Contacts

Public ContactYu Kyong Kim

Seoul National University Hospital

anace89@gmail.com+82-2-2740-4170

Outcome results