A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma

Phase 1 Completed 25 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.

Timeline

Start: 2016-09
Primary completion: 2016-11
Completion: 2016-11

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	30 mg	Oral
Subject	JNJ-54175446	Small molecule	100 mg	Oral
Subject	JNJ-54175446	Small molecule	300 mg	Oral

Indications

No indication recorded.