Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physica… (NCT05026164) | Clinical Trial Compass
CompletedPhase 2
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
United States40 participantsStarted 2021-12-13
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Timeframe: Day 2
2
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Timeframe: Day 3
3
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Timeframe: Day 4
4
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Timeframe: Day 2
5
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Timeframe: Day 3
6
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Timeframe: Day 4
7
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Timeframe: Day 2
8
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
. 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.
Timeframe: Day 3
9
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Timeframe: Day 4
10
Total number of Adverse Events [Safety and Tolerability]
Timeframe: Through study completion (Day 4)
11
Total number of participants with Adverse Events [Safety and Tolerability]
Timeframe: Through study completion (Day 4)
12
Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]