NCT06713447

NTI164 Human PK Study

A Pharmacokinetic Study of NTI164 in Healthy Adult Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fenix Innovation Group · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This open-label study aims to assess the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract containing 0.08% THC (NTI164) in healthy adult volunteers. The main objective is to characterise the pharmacokinetic (PK) profile of NTI164 in the body. This study is split into 2 Parts, with NTI164 delivered orally twice daily at a dose of 20mg/kg/day (i.e. 2 x 10mg/kg doses), and blood and urine samples collected in both parts. Part A involves only one day of NTI164 administration. In Part A, an oral dose of NTI164 will be administered to participants in a fasted state in the morning (AM). Blood samples will be collected at pre-dose and then 0.5, 2, 4, 6, and 8 hours following the AM dose. In the evening (PM), participants will receive another dose of NTI164 and bloods will be collected pre-PM dose, and 0.5, 2, 4, 6, 8, 12, and 24 hours following the PM dose. On Day 3 and 4, only one blood sample will be collected in the morning. Urine samples will be collected pre-AM dose, as well as 4, 8, 12, and 24 hours following, and 4, 8, 16, and 24 hours following the PM dose. Following the 24-hour post-PM dose urine sample, urine samples will be collected every 6 hours until 72 hours after the initial AM dose on Day 1 (i.e. AM on Day 4). Following blood and urine sample collection on Day 4, participants may be discharged from the clinical facility and will return on Day 7 to provide a final blood and urine sample. A follow-up phone call will be made to participants on Day 14 to ensure no adverse events have occurred and there are no concerns. In Part B, NTI164 will be administered for 7 consecutive days. Participants will not need to be fasted for Part B. On Day 1 (day of first dose), blood samples will be collected at pre-dose and then 0.5, 2, 4, 6, and 8 hours following the AM dose. In the evening (PM), participants will receive another dose of NTI164, and bloods will be collected 0.5, 2, 4, 6, 8, 12, and 24 hours following the PM dose. Urine samples will be collected pre-AM dose, as well as 4, 8, 12, and 24 hours following, and 4, 8, 16, and 24 hours following the PM dose. On Day 3, blood and urine samples will be collected pre-AM dose, and participants will be discharged and will continue at-home administration of NTI164. Participants will return on Day 6 as intensive blood and urine sampling will occur once again on Day 7. On Day 7, blood samples will be collected at pre-dose and then 0.5, 2, 4, 6, 8, and 12 hours following the AM dose. In the evening (PM), participants will receive another dose of NTI164 (FINAL dose of the study), and bloods will be collected 0.5, 2, 4, and 24 hours (Day 8) following the PM dose. Urine samples will be collected pre-AM dose, as well as 4, 8, 12, and 24 hours following, and 4, 8, 16, and 24 hours following the PM dose. The PM dose on Day 7 will be the final dose of NTI164 administered, however, participants will need to remain in the clinical facility on Day 8 for sample collection. A final blood and urine sample will be collected Day 9 AM, and then participants will be discharged from the clinical facility. Participants will return to the clinical facility for a blood and urine sample in the morning on Day 14, and also on Day 21 for a follow-up visit and final blood sample (no urine to be collected at this visit). This will mark the end of the study.

Conditions

• Healthy
• Healthy Volunteer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-12-03
• Last updated: 2025-03-19

Locations

1 site across 1 country: Australia