Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

July 3, 2017

Study Completion Date

July 31, 2017

Conditions
Healthy
Interventions
DRUG

Cenobamate

12.5 mg q.d.(Days 13-26), 25 mg q.d. (Days 27-40), 50 mg q.d. (Days 41-54), 100 mg q.d. (Days 55-70), 150 mg q.d. (Days 71-84), 200 mg q.d. (Days 85-110)

DRUG

midazolam

2 mg midazolam syrup (Days 7, 69, 105)

DRUG

Warfarin Pill

5 mg (Days 7 and 105)

DRUG

Omeprazole Pill

20 mg (Days 7 and 105)

DRUG

Bupropion Pill

150 mg (Days 1 and 99)

Trial Locations (1)

66212

Vince and Associates Clinical Research, Inc., Overland Park

All Listed Sponsors
lead

SK Life Science, Inc.

INDUSTRY

NCT03234699 - Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions | Biotech Hunter | Biotech Hunter