Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

Phase 1 Completed 26 enrolled Intra-Cellular Therapies, Inc. Laureate Institute for Brain Research, Inc. · collab

RandomizedCrossoverTriple-blindBasic science

Summary

This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.

Timeline

Start: 2018-07-10
Primary completion: 2019-08-05
Completion: 2019-08-05

Publications

Khalsa SS, Victor TA, Kuplicki R, Yeh HW, Vanover KE, Paulus MP, Davis RE. Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. Neuropsychopharmacology. 2022 Sep;47(10):1844-1853. doi: 10.1038/s41386-022-01331-3. Epub 2022 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenrispodun	Small molecule	1 mg	Oral
Subject	Lenrispodun	Small molecule	10 mg	Oral

Indications

No indication recorded.