Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine

PHASE1CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

April 30, 2023

Study Completion Date

May 31, 2023

Conditions
Major Depressive Disorder
Interventions
DRUG

(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.

DRUG

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.

Trial Locations (1)

27710

Duke Early Phase Clinical Research, Durham

All Listed Sponsors
lead

National Institute of Mental Health (NIMH)

NIH

NCT04711005 - Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine | Biotech Hunter | Biotech Hunter