drugset / Trial / NCT03180762

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants

NCT03180762 ↗

Phase 1 Terminated 36 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 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 PK of JNJ-64140284 following single oral dose administration.

Timeline

Start
2017-05-30
Primary completion
2017-09-25
Completion
2017-09-25

Outcome

Outcome not reported

Stopped: “Trial stopped: A SAE has occured. As a measure of precaution, the trial has been stopped.”

Drugs

EvaluationDrugModalityDoseRoute
Subject JNJ-64140284 Unknown 0.1 mg Oral
Subject JNJ-64140284 Unknown 0.5 mg Oral
Subject JNJ-64140284 Unknown 2.5 mg Oral
Subject JNJ-64140284 Unknown 10 mg Oral
Subject JNJ-64140284 Unknown 50 mg Oral
Subject JNJ-64140284 Unknown 150 mg Oral

Indications

No indication recorded.