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

NCT05210634 | Completed Phase 1

• 1 other identifier: 710022US1312
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (36)

• 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 Outcomes (24)

• Maximum effect for the item "energetic" on the DEQ

  Day 1

• Maximum effect for the item "energetic" on the DEQ

  Day 8

• Maximum effect for the item "energetic" on the DEQ

  Day 15

• Maximum effect for the item "energetic" on the DEQ

  Day 22

• Maximum effect for the item "energetic" on the DEQ

  Day 29

Study Arms (6)

Group 1: Placebo

PLACEBO COMPARATOR

Single oral administration of 4 ml of Placebo MCT oil

Dietary Supplement: THCv

Group 2: 12.5 mg THCv (CHI-915)

ACTIVE COMPARATOR

Single oral administration of 12.5 mg THCv in MCT oil

Dietary Supplement: THCv

Group 3: 25 mg THCv (CHI-915)

ACTIVE COMPARATOR

Single oral administration of 25 mg THCv in MCT oil

Dietary Supplement: THCv

Group 4: 50 mg THCv (CHI-915)

ACTIVE COMPARATOR

Single oral administration of 50 mg THCv in MCT oil

Dietary Supplement: THCv

Group 5: 100 mg THCv (CHI-915)

ACTIVE COMPARATOR

Single oral administration of 100 mg THCv in MCT oil

Dietary Supplement: THCv

Group 6: 200 mg THCv (CHI-915)

ACTIVE COMPARATOR

Single oral administration of 200 mg THCv in MCT oil

Dietary Supplement: THCv

Interventions

THCv DIETARY_SUPPLEMENT

THCv in MCT oil

Group 1: Placebo; Group 2: 12.5 mg THCv (CHI-915); Group 3: 25 mg THCv (CHI-915); Group 4: 50 mg THCv (CHI-915); Group 5: 100 mg THCv (CHI-915); Group 6: 200 mg THCv (CHI-915)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy adult aged 18-55 years (inclusive) at the time of screening.
• Has a body mass index between 18 and 30 kg/m2.
• 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.
• 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.
• Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
• Is, in the Investigator's opinion, reliable, able, and willing to comply with all protocol requirements and procedures (including scheduled visits).

You may not qualify if:

• Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
• 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.
• 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).
• Has a history of epilepsy.
• Has used tobacco/nicotine-containing products on more than 10 occasions within 30 days of dosing with study IP or during the study.
• 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.
• Use of any over-the-counter drugs, vitamins, or supplements within 24 hours prior to dosing with the IP.
• 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.
• 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.
• 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.
• 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.
• Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study medication or during the study.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Canopy Growth Corporation: lead

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Publications (2)

• Sempio C, Campos-Palomino J, Klawitter J, Peters EN, MacNair L, Haghdoost M, Bonn-Miller MO, Harrison A, Babalonis S, Christians U, Klawitter J. Pharmacokinetics of Oral Cannabinoid Delta8-Tetrahydrocannabivarin and Its Main Metabolites in Healthy Participants. Pharmaceuticals (Basel). 2024 Nov 27;17(12):1603. doi: 10.3390/ph17121603.

  PMID: 39770444 DERIVED

• Peters EN, MacNair L, Harrison A, Feldner MT, Eglit GML, Babalonis S, Turcotte C, Bonn-Miller MO. A Two-Phase, Dose-Ranging, Placebo-Controlled Study of the Safety and Preliminary Test of Acute Effects of Oral Delta8-Tetrahydrocannabivarin in Healthy Participants. Cannabis Cannabinoid Res. 2023 Sep;8(S1):S71-S82. doi: 10.1089/can.2023.0038.

  PMID: 37721990 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Phase 1 will follow a single-ascending dose design in 3 participants. This portion of the study will be unblinded. Phase 2 will follow a within-participant crossover design in 15 participants. Participants will be randomized to a dosing order. Phase 2 is double-blind.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The is a two-phase, within participant crossover study.

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 27, 2022
• Study Start: January 11, 2022
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

US (1)