drugset / Trial / NCT06713447
NTI164 Human PK Study
Phase 1
Active not recruiting
12 enrolled
Fenix Innovation Group
CMAX Clinical Research Pty Ltd · collabNeurotech International Limited · collab
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NTI164 | Traditional medicine (herbal / TCM) | 10 mg/kg | Oral |
Indications
No indication recorded.