Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CHI-915 in Healthy Participants

A Two-Phase, Randomized, Double-Blind, PlaceboControlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CHI-915 in Healthy Participants

This is a two-phase, randomized, double-blind, placebo-controlled, within-participant crossover study to assess the safety, tolerability, PK, and PD of five oral doses of CHI-915 versus placebo in healthy adult participants ages 18-55 years.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: THCv

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is a healthy adult aged 18-55 years (inclusive) at the time of screening.
2. Has a body mass index between 18 and 30 kg/m2.
3. Is judged by the Investigator to be in generally good health at screening based on the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range deemed to be acceptable will be documented as not clinically significant at the discretion of the Investigator.
4. For women of childbearing potential, has a negative serum pregnancy test (β-human chorionic gonadotropin [hCG]) at the Screening Visit and a negative urine pregnancy test at intake to the research facility.
5. Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
6. Is, in the Investigator's opinion, reliable, able, and willing to comply with all protocol requirements and procedures (including scheduled visits).

Exclusion Criteria:

1. Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
2. Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication. Participants with same sex partners or who maintain abstinence do not require contraception.
3. Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >3x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN) OR the ALT or aspartate aminotransferase (AST) >2 x ULN and TBL >2 x ULN (or international normalized ratio [INR] >1.5).
4. Has a history of epilepsy.
5. Has used tobacco/nicotine-containing products on more than 10 occasions within 30 days of dosing with study IP or during the study.
6. Has used any prescription drugs or herbal supplements (except hormonal contraception) within 30 days prior to receiving the first dose of IP, unless approved by the Investigator and stable for at least 30 days prior to the first dose of IP through the final study visit.
7. Use of any over-the-counter drugs, vitamins, or supplements within 24 hours prior to dosing with the IP.
8. Has or has previously had a positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCVAb), or human immunodeficiency virus (HIV) antibodies.
9. Has a positive breath, urine, or serum test for ethanol or a positive urine screen for cocaine, THC, barbiturates, amphetamines, methamphetamines, benzodiazepines, methylenedioxymethamphetamine, phencyclidine, methadone, or opiates at the Screening Visit or prior to IP administration.
10. Any clinically significant condition or abnormal finding at the Screening Visit that would, in the opinion of the Investigator, preclude study participation or interfere with evaluation of the IP.
11. Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP.
12. Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study medication or during the study.
13. Is taking a prohibited medication or supplement including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 30 days prior to receiving the first dose of IP or during the study.
14. Has used cannabis, synthetic cannabinoid, or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., spice, K2), or any cannabidiol (CBD) or THC-containing product (e.g., Sativex, Epidiolex) within 4 weeks of the Screening Visit or during the study and has used cannabis on more than 25 occasions in the last 12 months.
15. Meets criteria for past-year Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)-defined psychiatric disorder, or moderate to severe substance use disorder.
16. Has a lifetime history of psychosis or schizophrenia or a first-degree relative experiencing psychosis or schizophrenia.
17. Endorses current suicidal intent as indexed by endorsement of questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
18. Has suspected or confirmed cardiovascular disease.
19. Has participated in any investigational product or device study within 30 days prior to receiving the first dose of IP or is scheduled to participate in another investigational product or device study during the course of this study.
20. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1: Placebo; Single oral administration of 4 ml of Placebo MCT oil	Dietary supplement: THCv; THCv in MCT oil
Active Comparator: Group 2: 12.5 mg THCv (CHI-915); Single oral administration of 12.5 mg THCv in MCT oil	Dietary supplement: THCv; THCv in MCT oil
Active Comparator: Group 3: 25 mg THCv (CHI-915); Single oral administration of 25 mg THCv in MCT oil	Dietary supplement: THCv; THCv in MCT oil
Active Comparator: Group 4: 50 mg THCv (CHI-915); Single oral administration of 50 mg THCv in MCT oil	Dietary supplement: THCv; THCv in MCT oil
Active Comparator: Group 5: 100 mg THCv (CHI-915); Single oral administration of 100 mg THCv in MCT oil	Dietary supplement: THCv; THCv in MCT oil
Active Comparator: Group 6: 200 mg THCv (CHI-915); Single oral administration of 200 mg THCv in MCT oil	Dietary supplement: THCv; THCv in MCT oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 1
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 8
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 15
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 22
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 29
Incidence, type and severity of AEs/SAEs	Incidence, type and severity of AEs/SAEs	Day 36
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 1
Change in heart rate	Change in heart rate measured in beats per minute	Day 1
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 1
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 1
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 8
Change in heart rate	Change in heart rate measured in beats per minute	Day 8
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 8
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 8
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 15
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 15
Change in heart rate	Change in heart rate measured in beats per minute	Day 15
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 15
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 22
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 22
Change in heart rate	Change in heart rate measured in beats per minute	Day 22
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 22
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 29
Change in heart rate	Change in heart rate measured in beats per minute	Day 29
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 29
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 29
Change in blood pressure	Change in systolic and diastolic blood pressure measured in mmHg	Day 36
Change in heart rate	Change in heart rate measured in beats per minute	Day 36
Change in respiratory rate	Change in respiratory rate measured in breaths per minute	Day 36
Change in body temperature	Change in body temperature measured in degrees Celsius	Day 36
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 1
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 8
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 15
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 22
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 29
Change in ECG results	Change in ECG results. Results summarized as Normal, Abnormal not clinically significant, and Abnormal clinically significant	Day 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 1
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 8
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 15
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 22
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 29
Maximum effect for the item "energetic" on the DEQ	Maximum effect for the item "energetic" on the Drug Effects Questionnaire. Scale from 0-100 where higher scores indicate more "energetic"	Day 36
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 1
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 8
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 15
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 22
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 29
Sustained attention - maximum total time on the DVT	Sustained attention - maximum total time on the DVT	Day 36
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 1
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 8
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 15
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 22
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 29
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by maximum observed plasma concentration	Day 36
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 1
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 8
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 15
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 22
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 29
Pharmacokinetic profile of THCv	Pharmacokinetic profile of THCv measured by time to maximum observed plasma concentration	Day 36

Collaborators and Investigators

• Sponsor: Canopy Growth Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 710022US1312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No