Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity

Canopy Growth Corporation40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Delayed Onset Muscle Soreness (DOMS)

Interventions

CHI-202DIETARY_SUPPLEMENT

Blend of cannabinoids \& other ingredients

CHI-101DIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

International Society for Sports Nutrition

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]

Blood pressure is measure by the combination of systolic and diastolic measurements

Time frame: Day 2

Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]

Blood pressure is measure by the combination of systolic and diastolic measurements

Time frame: Day 3

Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]

Blood pressure is measure by the combination of systolic and diastolic measurements

Time frame: Day 4

Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]

Respiratory rate will be measured as breaths per minute

Time frame: Day 2

Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]

Respiratory rate will be measured as breaths per minute

Time frame: Day 3

Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]

Respiratory rate will be measured as breaths per minute

Time frame: Day 4

Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]

Heart rate will be measured as heart beats per minute

Time frame: Day 2

Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]

Heart rate will be measured as heart beats per minute

Data from ClinicalTrials.gov

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Secondary Outcomes

Average soreness or discomfort intensity using the 11-point (0-10) NRS

Self-reported average soreness or discomfort intensity using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 1 - post DOMS intervention

Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 2

Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 3

Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 4

Worst soreness or discomfort intensity using the 11-point (0-10) NRS

Self-reported worst soreness or discomfort intensity using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 1 - post DOMS intervention

Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 2

Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 3

Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

Time frame: Day 4

Average stiffness intensity using the 11-point (0-10) NRS

Self-reported average stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 1 - post DOMS intervention

Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 2

Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 3

Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 4

Worst stiffness intensity using the 11-point (0-10) NRS

Self-reported worst stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 1 - post DOMS intervention

Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 2

Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 3

Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

Time frame: Day 4

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

Self-reported 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 where 10 is most interference

Time frame: Day 2

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

Time frame: Day 3

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

Time frame: Day 4

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

Self-reported 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 where 10 is most interference

Time frame: Day 2

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

Time frame: Day 3

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

Time frame: Day 4

Self-reported sleep quality using the 11-point (0-10) NRS

Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality

Time frame: Day 2

Self-reported sleep quality using the 11-point (0-10) NRS

Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality

Time frame: Day 3

Self-reported sleep quality using the 11-point (0-10) NRS

Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality

Time frame: Day 4

Self-reported sleep duration via a sleep diary

Self-reported sleep duration measured in minutes via a sleep diary

Time frame: Day 2

Self-reported latency to sleep onset via a sleep diary

Self-reported latency to sleep onset measured in minutes via a sleep diary

Time frame: Day 2

Self-reported sleep continuity via a sleep diary

Self-reported sleep continuity measured in minutes via a sleep diary

Time frame: Day 2

Self-reported alertness upon waking via a sleep diary

Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy

Time frame: Day 2

Self-reported sleep duration via a sleep diary

Self-reported sleep duration measured in minutes via a sleep diary

Time frame: Day 3

Self-reported latency to sleep onset via a sleep diary

Self-reported latency to sleep onset measured in minutes via a sleep diary

Time frame: Day 3

Self-reported sleep continuity via a sleep diary

Self-reported sleep continuity measured in minutes via a sleep diary

Time frame: Day 3

Self-reported alertness upon waking via a sleep diary

Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy

Time frame: Day 3

Self-reported sleep duration via a sleep diary

Self-reported sleep duration measured in minutes via a sleep diary

Time frame: Day 4

Self-reported latency to sleep onset via a sleep diary

Self-reported latency to sleep onset measured in minutes via a sleep diary

Time frame: Day 4

Self-reported sleep continuity via a sleep diary

Self-reported sleep continuity measured in minutes via a sleep diary

Time frame: Day 4

Self-reported alertness upon waking via a sleep diary

Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy

Time frame: Day 4

Pressure threshold

Pressure threshold measured with a 25-lb algometer

Time frame: Day 1 - post DOMS intervention

Pressure threshold

Pressure threshold measured with a 25-lb algometer

Time frame: Day 2

Pressure threshold

Pressure threshold measured with a 25-lb algometer

Time frame: Day 3

Pressure threshold

Pressure threshold measured with a 25-lb algometer

Time frame: Day 4

Relaxed elbow angle

Relaxed elbow angle measured with a goniometer in degrees

Time frame: Day 1 - post DOMS intervention

Active range of motion

Active range of motion measured with a goniometer in degrees

Time frame: Day 1 - post DOMS intervention

Passive range of motion

Passive range of motion measured with a goniometer in degrees

Time frame: Day 1 - post DOMS intervention

Relaxed elbow angle

Relaxed elbow angle measured with a goniometer in degrees

Time frame: Day 2

Active range of motion

Active range of motion measured with a goniometer in degrees

Time frame: Day 2

Passive range of motion

Passive range of motion measured with a goniometer in degrees

Time frame: Day 2

Relaxed elbow angle

Relaxed elbow angle measured with a goniometer in degrees

Time frame: Day 3

Active range of motion

Active range of motion measured with a goniometer in degrees

Time frame: Day 3

Passive range of motion

Passive range of motion measured with a goniometer in degrees

Time frame: Day 3

Relaxed elbow angle

Relaxed elbow angle measured with a goniometer in degrees

Time frame: Day 4

Active range of motion

Active range of motion measured with a goniometer in degrees

Time frame: Day 4

Passive range of motion

Passive range of motion measured with a goniometer in degrees

Time frame: Day 4

Muscle circumference

Time frame: Day 1 - post DOMS intervention

Muscle circumference

Time frame: Day 2

Muscle circumference

Time frame: Day 3

Muscle circumference

Time frame: Day 4

Mood using the Profile of Mood States

Time frame: Day 1 - post DOMS intervention

Mood using the Profile of Mood States

Time frame: Day 2

Mood using the Profile of Mood States

Time frame: Day 3

Mood using the Profile of Mood States

Time frame: Day 4