NN08 NCATS (18-01) (Healthy Volunteers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug, (2R, 6R)-Hydroxynorketamine, is safe for those with depression that has not responded to treatment.

What is the Condition Being Studied?

Depression that has not responded to treatment

Who Can Participate in the Study?

Adults, 18-65 years old who are:
-Healthy and do not have medical problems
-Can stay at our inpatient unit

Age Group

What is Involved?

If you choose to join this study, you will:
-Have a physical exam
-Have an electrocardiogram (ECG), a scan to look at your heart
-Electroencephalogram (EEG), a scan to look at your brain activity
-Give blood and urine samples
-Complete questionnaires
-Have a 2 night inpatient stay
-Complete 1 clinic visit and a follow-up phone call

For more information about this study and other clinical research opportunities,
please complete our https://volunteer.dcru.org/p1vw/ Registry Survey and we will contact you.

Study Details

Full Title
NN08 NCATS (18-01): A Double-Blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of the Safety, Pharmacokinetics and Pharmacodynamics of (2R,6R)-Hydroxynorketamine in Healthy Volunteers.
Principal Investigator
Protocol Number
IRB: PRO00106558
NCT: NCT04711005
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center