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A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Subjects
The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 71 |
| Start date | 2017-01 |
| Completion | 2017-10 |
Conditions
- Healthy
Interventions
- JNJ-61393215
- Placebo
Primary outcomes
- Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability — up to 4 weeks
- Time To Reach The Maximum Plasma Concentration (Tmax) — Day 1
Tmax is time to reach the maximum plasma concentration. - Maximum Plasma Concentration (Cmax) — Day 1
Cmax is maximum plasma concentration. - Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) — Day 1
AUC\[0-24\] is area under the plasma concentration- time curve from time \[0 to 24\]. - The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough) — Days 2 to 6
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose. - The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough) — Day 7
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Countries
Netherlands