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

NCT04711005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-06-06

Study results available
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Summary

A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 2-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 8, and 11. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels. Finally, a single-cohort group with received a single dose by slow-infusion IV and have PK samples collected from both blood and cerebrospinal fluid (CSF).

Conditions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Shruti Raja, MD, MHS · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-04-30
Completion
2023-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711005 on ClinicalTrials.gov