A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy Participants

Phase 1 Completed 76 enrolled Janssen-Cilag International NV

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-54175446 versus placebo after single oral dose administration (ascending dose levels), to determine the maximal tolerated dose (MTD) or the safety and tolerability at exposures resulting in full target engagement for at least 24 hours in all participants (whichever comes first), to characterize the pharmacokinetics of JNJ-54175446 in plasma, cerebrospinal fluid (CSF) and urine and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ 54175446 after single oral dose administration.

Timeline

Start: 2015-06
Primary completion: 2015-10
Completion: 2015-10

Publications

Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-54175446	Small molecule	0.5 mg	Oral
Subject	JNJ-54175446	Small molecule	2.5 mg	Oral
Subject	JNJ-54175446	Small molecule	10 mg	Oral
Subject	JNJ-54175446	Small molecule	30 mg	Oral
Subject	JNJ-54175446	Small molecule	100 mg	Oral
Subject	JNJ-54175446	Small molecule	200 mg	Oral

Indications

No indication recorded.