Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Unknown status
SK Life Science
Phase 2
2011-05-01
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
to baseline in subjects with partial onset seizures not fully controlled despite their
treatment with 1 to 3 concomitant anti-epileptic drugs.
Also to evaluate the safety and tolerability of YKP3089.
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Unknown status
SK Life Science, Inc.
Phase 2
2011-05-01
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
to baseline in subjects with partial onset seizures not fully controlled despite their
treatment with 1 to 3 concomitant anti-epileptic drugs.
Also to evaluate the safety and tolerability of YKP3089.
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions
Completed
SK Life Science
Phase 1
2017-02-22
This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5,
CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo
probes. In order to avoid a potential pharmacokinetic interaction between the probes,
midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together
as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time
period between the 2 assessments.
The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2
weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg,
150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady
state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day
of cenobamate for all CYP probes.
The results of this DDI study will provide a basis to make appropriate dose recommendation
for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic
pathway.
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