Your session is about to expire
← Back to Search
NMDA receptor antagonist
(2R,6R)-Hydroxynorketamine hydrochloride for Depression
Phase 1
Waitlist Available
Led By Shruti Raja, MD, MHS
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post dosing (sad), 12 days post dosing (mad)
Awards & highlights
Study Summary
This trial will test the safety and effects of a new drug given in different doses to healthy volunteers. The volunteers will have their standard safety parameters monitored, and the effects of the drug on their bodies will be studied.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days post dosing (sad), 12 days post dosing (mad)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post dosing (sad), 12 days post dosing (mad)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, area under the curve concentration (AUC)
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, half-life (t1/2)
+2 moreSecondary outcome measures
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) relative spectral power
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) source localization
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) visual evoked time-locked data
Trial Design
10Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohort 6Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes)
Group II: SAD Cohort 5Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes)
Group III: SAD Cohort 4Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes)
Group IV: SAD Cohort 3Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes)
Group V: SAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group VI: SAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes)
Group VII: MAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group VIII: MAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group IX: CSF Capture Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group X: PlaceboPlacebo Group1 Intervention
Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(2R,6R)-Hydroxynorketamine hydrochloride
2021
Completed Phase 1
~80
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,798 Previous Clinical Trials
2,660,844 Total Patients Enrolled
673 Trials studying Depression
253,343 Patients Enrolled for Depression
Shruti Raja, MD, MHSPrincipal InvestigatorDuke University
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger