drugset
drugset / Trial / NCT02812251

Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants

NCT02812251 ↗

Phase 1 Completed 80 enrolled Janssen-Cilag International NV
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral dose administration.

Timeline

Start
2016-07-07
Primary completion
2016-11-17
Completion
2016-11-17

Drugs

EvaluationDrugModalityDoseRoute
Subject TEBITOREXANT Small molecule 1 mg Oral
Subject TEBITOREXANT Small molecule 5 mg Oral
Subject TEBITOREXANT Small molecule 15 mg Oral
Subject TEBITOREXANT Small molecule 30 mg Oral
Subject TEBITOREXANT Small molecule 45 mg Oral
Subject TEBITOREXANT Small molecule 60 mg Oral
Subject TEBITOREXANT Small molecule 90 mg Oral
Subject TEBITOREXANT Small molecule 120 mg Oral

Indications

No indication recorded.