drugset
drugset / Trial / NCT03649997

A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

NCT03649997 ↗

Phase 1 Completed 57 enrolled Janssen Research & Development, LLC
RandomizedSequentialDouble-blindOther

Summary

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.

Timeline

Start
2018-08-28
Primary completion
2018-12-14
Completion
2018-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject TEBITOREXANT Small molecule 30 mg Oral
Subject TEBITOREXANT Small molecule 145 mg Oral
Subject TEBITOREXANT Small molecule 225 mg Oral

Indications

No indication recorded.