Assessment of Effect of Rapastinel on Driving Performance

Phase 1 Completed 107 enrolled Naurex, Inc

RandomizedCrossoverDouble-blindOther

Summary

Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.

Timeline

Start: 2018-11-05
Primary completion: 2019-03-29
Completion: 2019-04-03

Publications

Su S, Kay G, Hochadel T, Rojo J, Christopher Stein J, Boinpally R, Periclou A. A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance. Clin Transl Sci. 2022 Jan;15(1):255-266. doi: 10.1111/cts.13145. Epub 2021 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Alprazolam	Small molecule	0.75 mg	Oral
Comparator	Ketamine	Small molecule	0.5 mg/kg	Intravenous
Subject	Rapastinel	Other / unclassified	900 mg	Intravenous
Subject	Rapastinel	Other / unclassified	1800 mg	Intravenous

Indications

No indication recorded.