NTI164 Human PK Study

NCT06713447 | Active Not Recruiting Phase 1

• 1 other identifier: FENPK1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetic; Healthy; Cannabis

Outcome Measures

Primary Outcomes (1)

• Peak plasma concentration (Cmax)

  Maximum concentration of the drug at timepoints: baseline (pre-dose), 1, 2, 3, 4, 5, 12, 24 hrs post commencement of treatment, and daily up to 7 days post-dose for Part A and 21 days for Part B.

  Up to 21 days

Secondary Outcomes (1)

• Ae t1-t2 - urine

  Up to 21 days

Study Arms (1)

NTI164 active

EXPERIMENTAL

All participants will be in this arm (single intervention) and will receive NTI164.

Drug: NTI164

Interventions

NTI164 DRUG

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.

NTI164 active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and AEs.
• Adult males and females, 18 to 65 years of age (inclusive) at screening.
• BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 50 kg.
• Medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant abnormalities. Must have:
• Physical examination without any clinically relevant findings;
• Systolic blood pressure (BP) in the range of 90 to 145 mmHg and diastolic BP in the range of 50 to 95 mmHg after resting for 5 minutes in a supine position.
• Pulse rate in the range of 45 to 100 bpm after 5 minutes resting in a supine position.
• Body temperature (tympanic), between 35.5°C and 37.7°C.
• Electrocardiogram (ECG) without clinically significant abnormalities including QT interval corrected for Fredericia (QTcF) \<450 msec, QRS interval \< 120 msec and PR interval \< 220 msec, based on the average of triplicate measurements.
• No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests.
• Female participants:
• Must be of non-child-bearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (with postmenopausal defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or
• If of child-bearing potential, must:
• i. Have a negative pregnancy test at the screening visit and on admission to the study site on Day-1. ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 30 days after the last dose of study drug. iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception (e.g. hormonal contraception, intrauterine device, bilateral tube occlusion, etc.) from one month prior to screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
• Male participants:

You may not qualify if:

• Known hypersensitivity to any of the study drug ingredients.
• History of anaphylaxis or other significant allergy (including system sensitivity to any aerosol) which, in the opinion of the Investigator, would interfere with the participant's ability to participate in the study.
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the Investigator to be clinically relevant.
• Current diagnosis of bipolar disorder, major depressive disorder, psychosis, schizophrenia, or schizoaffective disorder.
• History of major surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study.
• History of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
• Clinically relevant history or presence of rhythm disorders (e.g. sinoatrial heart block, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation), clinically-relevant history of hypokalaemia, congestive heart failure, or structural heart disease.
• Presence or having sequelae of gastrointestinal, liver (with the exception of Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Serum or plasma potassium \<3.5 or \>5.2 mmol/L, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN), or total bilirubin \>2 x ULN at screening or Day -1 (except for Gilbert's syndrome).
• History of or positive test results for HIV, HBsAg, or HCV antibodies at screening.
• Positive drugs of abuse test, urine cotinine test, and/or urine alcohol test results at screening and/or on admission to the clinical facility on Day -1.
• History or clinical evidence of alcoholism or drug abuse (in the opinion of the Investigator) within the 3-year period prior to screening.
• Regular consumption of \>10 standard alcoholic beverages/week, where 1 standard drink is 10g of pure alcohol and is equivalent to 285 mL beer (4.9% Alc/Vol), 100 mL wine (12% Alc/Vol), or 30mL spirit (40% Alc/Vol).
• Excessive caffeine consumption, defined as ≥ 800 mg per day at screening (1 cup of coffee contains \~100 mg caffeine, 1 cup of tea or one glass of cola contains \~40 mg caffeine, 1 can of Red Bull contains \~80 mg caffeine).
• Females who are pregnant, breastfeeding, or planning to breastfeed.

Sponsors & Collaborators

• Fenix Innovation Group: lead
• CMAX Clinical Research Pty Ltd: collaborator
• Neurotech International Limited: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single intervention, single site pharmacokinetic study.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 3, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)