A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers

This Phase I trial (n=24) will investigate the safety, tolerability, and pharmacokinetics of NeuroDirect Ketamine in healthy adult volunteers.

The study aims to test single doses of NeuroDirect Ketamine at three different levels: 25 mg (Cohort 1), 50 mg (Cohort 2), and 100 mg (Cohort 3) in a single-ascending dose study. Each cohort will consist of 8 participants, with 6 receiving NeuroDirect Ketamine and 2 receiving a placebo.

The primary outcome is to assess the safety and tolerability of NeuroDirect Ketamine following a single topical dose administration, while the secondary outcome is to characterise the pharmacokinetic properties of NeuroDirect Ketamine and its major metabolite, norketamine, in plasma, cerebrospinal fluid (CSF), and urine.

The study is interventional, randomised, double-blind, and placebo-controlled. Participants must be healthy adults aged between 18 to 60 years and meet specific inclusion and exclusion criteria. The trial is not yet recruiting, with an anticipated start date of 13/03/2023.

It is funded by Psycheceutical, Inc., and the principal investigator is Dr. Ofer Gonen from Nucleus Network in Melbourne, Australia.

Topic Healthy Subjects
Compound Ketamine Placebo
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 13 March 2023
End date 02 May 2025
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 24
Sex All
Age 18- 60
Therapy No

Trial Details

A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, of NeuroDirect Ketamine in Healthy Adult Volunteers

NCT Number ACTRN12623000061639p

Sponsors & Collaborators

Psycheceutical
Psycheceutical is focused on developing technologies to enhance the delivery of psychedelic medicines.

Data attribution

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