Clinical Trial

NTI164 Human PK Study

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated March 19, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is looking at how a new cannabis compound with extremely low THC (0.08%), NTI164, is metabolised in the body and how it is excreted in urine over time (up to 28 days) in healthy adult volunteers. NTI164 will be delivered twice daily, at a concentration of 20mg/kg/day. There will be 2 parts to this study, Part A and Part B. Part A involves only one day of taking NTI164, whereas Part B involves taking NTI164 for 7 consecutive days. Urine samples and blood samples will be collected at certain time points after NTI164 dosing to help characterise how the drug is being broken down in the body and over what time frame.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-27.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-03-15
Trial Details
NCT Number NCT06713447
Lead Sponsor Fenix Innovation Group
Collaborators: CMAX Clinical Research Pty Ltd, Neurotech International Limited
Conditions Healthy, Healthy Volunteer
Enrollment 12 participants
Start Date 2024-02-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-19