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NTI164 Human PK Study

NCT06713447 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Healthy
  • Healthy Volunteer

Interventions

DRUG

NTI164

This intervention uses Full-Spectrum Medicinal Cannabis Plant Extract with a low THC concentration of 0.08% (NTI164) specifically formulated to target inflammation in various neurological conditions. The dose of 20mg/kg has been selected based off existing clinical trial evidence for NTI164, and is similar to the dose of other cannabis-based drugs used in neurology. The safety of NTI164 has been rigorously tested in several ongoing paediatric clinical trials through blood tests and clinician-rated surveys.

Sponsors & Collaborators

  • CMAX Clinical Research Pty Ltd

    collaborator UNKNOWN

  • Neurotech International Limited

    collaborator INDUSTRY

  • Fenix Innovation Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Australia

Study Locations

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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 NCT06713447 on ClinicalTrials.gov