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

NCT05026164 | Completed Phase 2 DMC

• 1 other identifier: 710US-1311
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Delayed Onset Muscle Soreness (DOMS)

Outcome Measures

Primary Outcomes (12)

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

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

  Day 2

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

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

  Day 3

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

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

  Day 4

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

  Respiratory rate will be measured as breaths per minute

  Day 2

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

  Respiratory rate will be measured as breaths per minute

  Day 3

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

  Respiratory rate will be measured as breaths per minute

  Day 4

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

  Heart rate will be measured as heart beats per minute

  Day 2

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

  Heart rate will be measured as heart beats per minute

  Day 3

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

  Heart rate will be measured as heart beats per minute

  Day 4

• Total number of Adverse Events [Safety and Tolerability]

  Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events

  Through study completion (Day 4)

• Total number of participants with Adverse Events [Safety and Tolerability]

  Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events

  Through study completion (Day 4)

• Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]

  Safety and tolerability will be assessed through Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed)

  Through study completion (Day 4)

Secondary Outcomes (61)

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

  Day 1 - post DOMS intervention

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

  Day 2

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

  Day 3

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

  Day 4

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

  Day 1 - post DOMS intervention

Study Arms (2)

Active

ACTIVE COMPARATOR

CHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily.

Dietary Supplement: CHI-202

Placebo

PLACEBO COMPARATOR

CHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily.

Dietary Supplement: CHI-101

Interventions

CHI-202 DIETARY_SUPPLEMENT

Blend of cannabinoids \& other ingredients

Active

CHI-101 DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy adult aged 18-65 years, inclusive, at the time of screening.
• 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.
• Has a body mass index between 18 and 35 kg/m2 (inclusive).
• Is judged by the Investigator to be in generally good health at screening based on participants' self-reported medical history.
• Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.

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.
• Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
• 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.
• 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.
• 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).
• Has musculoskeletal issues that might impede performing maximal elbow flexion exercises.
• 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.
• Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study IP.
• 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.
• 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.
• Endorses current suicidal intent.
• 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.
• Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
• Has a positive result on urine drug screen for cocaine, amphetamine, methamphetamine, THC, and opiates at the first study visit.

Sponsors & Collaborators

• Canopy Growth Corporation: lead

Study Sites (1)

International Society for Sports Nutrition

Boca Raton, Florida, 33432, United States

Location

Study Officials

• Erica Peters, PhD

  Canopy Growth Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 30, 2021
• Study Start: December 13, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

US (1)