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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
SK Life Science, Inc.
Study ID
NCT03234699
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Cenobamate — DRUG
    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)
  • midazolam — DRUG
    2 mg midazolam syrup (Days 7, 69, 105)
  • Warfarin Pill — DRUG
    5 mg (Days 7 and 105)
  • Omeprazole Pill — DRUG
    20 mg (Days 7 and 105)
  • Bupropion Pill — DRUG
    150 mg (Days 1 and 99)

Study Details

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.

Key Dates

Start date
Feb 22, 2017
Status verified
Sep 2024
Primary completion
Jul 3, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Group

Primary Outcome Measure

Pharmacokinetic parameters AUC [ Time Frame: bupropion (6 days), midazolam (24 hrs), omeprazole (24 hrs), warfarin (7 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vince and Associates Clinical Research, Inc.Overland ParkKansas66212-

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Vince and Associates Clinical Research, Inc.· Overland Park, KS

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