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An Open-Label Study to Evaluate the Pharmacokinetics of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Subjects
The primary purpose of this study is to evaluate the induction potential of repeated administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in healthy participants using orally administered midazolam and bupropion as probes, respectively and to evaluate the pharmacokinetics of esketamine after a single dose and repeated administration.
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 71 |
| Start date | 2015-10 |
| Completion | 2016-02 |
Conditions
- Healthy
Interventions
- Midazolam
- Esketamine
- Bupropion
Primary outcomes
- Maximum Plasma Concentration (Cmax) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
The Cmax is the maximum plasma concentration. - Time to reach maximum concentration (tmax) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
Time to reach the maximum observed plasma concentration. - Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant. - Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant. - Terminal Half-Life(t[1/2]) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
Terminal half-life (t\[(1/2\]) is defined as 0.693/Lambda(z). - Area Under the Plasma Concentration-Time Curve From Time Zero to 12 hours (AUC [0-12]) — up to Day 17 for Cohort 1; up to Day 19 for Cohort 2
The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Countries
Belgium