drugset / Trial / NCT04566926

A Study of JNJ-64140284 in Healthy Male Participants

NCT04566926 ↗

Phase 1 Terminated 33 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedParallel-groupDouble-blindOther

Summary

The purpose of the study is to investigate and compare the pharmacokinetic (PK) profiles of a single dose of two solid dosage formulations of JNJ-64140284 in plasma and urine in healthy male participants under fed and fasting conditions; and to investigate the safety and tolerability of two solid dosage formulations of JNJ 64140284 versus placebo after single oral dose administration in healthy male participants under fed and fasting conditions in Part 1; to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (or 1 divided dose, if applicable) (ascending dose levels) in healthy male participants; and to characterize the PK of a single dose (or 1 divided dose, if applicable) of JNJ-64140284 in plasma in healthy male participants in Part 2; and to investigate the effect of food on the PK of a single (or 1 divided dose, if applicable) therapeutic relevant dose of JNJ 64140284 in healthy male participants; and to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration at a therapeutic relevant dose (or 1 divided dose, if applicable) in fed conditions in Part 3.

Timeline

Start
2020-09-29
Primary completion
2021-04-05
Completion
2021-04-05

Outcome

Outcome not reported

Stopped (Business): “business decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject JNJ-64140284 Unknown — Oral

Indications

No indication recorded.