Clinical trial NCT05026164: Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
Official title: A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delayed Onset Muscle Soreness (DOMS)
Lead sponsor: Canopy Growth Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized
Primary purpose: OTHER

Brief summary: The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).

Detailed description: The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3 times per week for at least 30 minutes per session for the past year) will be recruited from existing panels of participants from past studies, local advertisements, and social media targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a given exercise, will be used in order to induce DOMS. Following the completion of the Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2, and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP to which they have been randomly assigned (i.e., active or placebo) with instruction to consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.

Eligibility criteria: Inclusion Criteria:

1. Is a healthy adult aged 18-65 years, inclusive, at the time of screening.
2. Is exercise-trained, i.e., self-reports exercising at least 3 times per week for at least 30 minutes per session for the past year.
3. Has a body mass index between 18 and 35 kg/m2 (inclusive).
4. Is judged by the Investigator to be in generally good health at screening based on participants' self-reported medical history.
5. Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.

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.
3. Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
4. Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the month prior to the Exercise Visit.
5. Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
6. 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 (e.g., coconut; coconut oil; medium-chain triglycerides).
7. Has musculoskeletal issues that might impede performing maximal elbow flexion exercises.
8. Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 30 days of the Exercise Visit or during the study.
9. Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study IP.
10. 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 4 weeks of the Exercise Visit or during the study.
11. 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.
12. Endorses current suicidal intent.
13. Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
14. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
15. Has a positive result on urine drug screen for cocaine, amphetamine, methamphetamine, THC, and opiates at the first study visit.

Primary outcomes:
measure: Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
timeFrame: Day 2
measure: Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
timeFrame: Day 3
measure: Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
timeFrame: Day 4
measure: Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
timeFrame: Day 2
measure: Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
timeFrame: Day 3
measure: Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
timeFrame: Day 4
measure: Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
timeFrame: Day 2
measure: Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
timeFrame: Day 3
measure: Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
timeFrame: Day 4
measure: Total number of Adverse Events [Safety and Tolerability]
timeFrame: Through study completion (Day 4)
measure: Total number of participants with Adverse Events [Safety and Tolerability]
timeFrame: Through study completion (Day 4)
measure: Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
timeFrame: Through study completion (Day 4)
Secondary outcomes:
measure: Average soreness or discomfort intensity using the 11-point (0-10) NRS
timeFrame: Day 1 - post DOMS intervention
measure: Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Worst soreness or discomfort intensity using the 11-point (0-10) NRS
timeFrame: Day 1 - post DOMS intervention
measure: Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Average stiffness intensity using the 11-point (0-10) NRS
timeFrame: Day 1 - post DOMS intervention
measure: Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Worst stiffness intensity using the 11-point (0-10) NRS
timeFrame: Day 1 - post DOMS intervention
measure: Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Self-reported sleep quality using the 11-point (0-10) NRS
timeFrame: Day 2
measure: Self-reported sleep quality using the 11-point (0-10) NRS
timeFrame: Day 3
measure: Self-reported sleep quality using the 11-point (0-10) NRS
timeFrame: Day 4
measure: Self-reported sleep duration via a sleep diary
timeFrame: Day 2
measure: Self-reported latency to sleep onset via a sleep diary
timeFrame: Day 2
measure: Self-reported sleep continuity via a sleep diary
timeFrame: Day 2
measure: Self-reported alertness upon waking via a sleep diary
timeFrame: Day 2
measure: Self-reported sleep duration via a sleep diary
timeFrame: Day 3
measure: Self-reported latency to sleep onset via a sleep diary
timeFrame: Day 3
measure: Self-reported sleep continuity via a sleep diary
timeFrame: Day 3
measure: Self-reported alertness upon waking via a sleep diary
timeFrame: Day 3
measure: Self-reported sleep duration via a sleep diary
timeFrame: Day 4
measure: Self-reported latency to sleep onset via a sleep diary
timeFrame: Day 4
measure: Self-reported sleep continuity via a sleep diary
timeFrame: Day 4
measure: Self-reported alertness upon waking via a sleep diary
timeFrame: Day 4
measure: Pressure threshold
timeFrame: Day 1 - post DOMS intervention
measure: Pressure threshold
timeFrame: Day 2
measure: Pressure threshold
timeFrame: Day 3
measure: Pressure threshold
timeFrame: Day 4
measure: Relaxed elbow angle
timeFrame: Day 1 - post DOMS intervention
measure: Active range of motion
timeFrame: Day 1 - post DOMS intervention
measure: Passive range of motion
timeFrame: Day 1 - post DOMS intervention
measure: Relaxed elbow angle
timeFrame: Day 2
measure: Active range of motion
timeFrame: Day 2
measure: Passive range of motion
timeFrame: Day 2
measure: Relaxed elbow angle
timeFrame: Day 3
measure: Active range of motion
timeFrame: Day 3
measure: Passive range of motion
timeFrame: Day 3
measure: Relaxed elbow angle
timeFrame: Day 4
measure: Active range of motion
timeFrame: Day 4
measure: Passive range of motion
timeFrame: Day 4
measure: Muscle circumference
timeFrame: Day 1 - post DOMS intervention
measure: Muscle circumference
timeFrame: Day 2
measure: Muscle circumference
timeFrame: Day 3
measure: Muscle circumference
timeFrame: Day 4
measure: Mood using the Profile of Mood States
timeFrame: Day 1 - post DOMS intervention
measure: Mood using the Profile of Mood States
timeFrame: Day 2
measure: Mood using the Profile of Mood States
timeFrame: Day 3
measure: Mood using the Profile of Mood States
timeFrame: Day 4
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: International Society for Sports Nutrition
state: Florida
Study officials:
affiliation: Canopy Growth Corporation
name: Erica Peters, PhD
role: STUDY_DIRECTOR
References: