74
Participants
Start Date
January 11, 2021
Primary Completion Date
April 30, 2023
Study Completion Date
May 31, 2023
(2R,6R)-Hydroxynorketamine hydrochloride
(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
Placebo
Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.
Duke Early Phase Clinical Research, Durham
National Institute of Mental Health (NIMH)
NIH