A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety and Pharmacokinetics of CHI-936 in Healthy Participants
- Conditions
- PainNauseaMuscle SpasticityEpilepsyAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12619001450101
- Lead Sponsor
- 10607410 CANADA INC. DBA Spectrum Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
1.Is a healthy male or female adult aged 18–55 years at the time of screening.
2.Has a minimum of 2 lifetime exposures to THC-containing cannabis products.
3.Has a body mass index between 18 and 30 kg/m2.
4.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.
5.For women of childbearing potential, has a negative serum pregnancy test (ß-human chorionic gonadotropin [hCG]) at the Screening Visit and a negative urine pregnancy test at intake to the inpatient research facility.
6.Agrees to abide by all study restrictions and comply with all study procedures.
7.Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
8.Is, in the Investigator’s opinion, reliable, able, and willing to comply with all protocol requirements and procedures (including scheduled visits and confinement periods).
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 do not require contraception.
3.Has a history of epilepsy.
4.Has used tobacco/nicotine-containing products on more than 5 occasions within 1 month of the Screening Visit or during the study.
5.Has used any prescription drugs or herbal supplements (except hormonal contraception) within four weeks prior to the Screening Visit, unless approved by the Investigator and stable for at least 4 weeks prior to Screening through the final study visit.
6.Use of any over-the-counter drugs, vitamins, or supplements within 72 hours prior to the first dose of study medication.
7.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.
8.Has a positive breath 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 study treatment.
9.Has a history of psychosis or schizophrenia, including among first-degree relatives.
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 study treatment.
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 IMP.
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 including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John’s Wort within 30 days of the Screening Visit 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 CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 8 weeks of the Screening Visit or during the study.
15.Has a history of treatment for or exhibits evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 2 units of alcohol per day.
16.Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the subject’s ability to comply with the study requirements.
17.Has a history of suicidal behavior or any active suicidal ideation as indexed by endorsement of questions #4 or #5 on the C-SSRS.
18.Has suspected or confirmed cardiovascular disease.
19.Has participated in any investigational product or d
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of CHI-936 administered twice daily for a total daily dose of 120 mg CBD and 5.4 mg THC, 240 mg CBD and 10.8 mg THC, 360 mg CBD and 16.2 mg THC, or 480 mg CBD and 21.6 mg THC.[For 7 consecutive days relative to placebo.<br><br>Patient safety will be monitored at all visits and during the inpatient Treatment Period using standard measures including physical examinations, vital sign assessments, 12 lead electrocardiogram (ECG), safety laboratory analyses, urinalysis, and adverse event (AE) monitoring. Additionally, the Columbia Suicide Severity Rating Scale (C-SSRS) will be administered at screening, pre-morning dose on Days 1 through 7, at Inpatient Discharge on Day 8, and at Visit 6 (Day 13). ]
- Secondary Outcome Measures
Name Time Method