A double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of product formulations containing mitragynine and their relative effects on exercise-induced muscle soreness in healthy adult participants.

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy males and females who are 18 to 55 years of age (inclusive). * In good general health as deemed by the investigator and are able to consume the study product. * Have a BMI between 18.0 to 34.9 kg/m2 (inclusive). * Naïve to kratom use or occasional kratom use (i.e., have not used kratom more than once within 28 days prior to baseline \[Visit 2\]). * Non-smokers (including nicotine vaping) and have not used nicotine-containing products (patches, gums, etc.) for \> 3 months prior to baseline (Visit Note: Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine. * Appropriate for exercise as determined by the PAR-Q at screening (Visit 1A). * Demonstrate DOMS 48 h post-exercise by having a VAS ≥ 40 mm after completion of the exercise challenge at Visit 1A. * Agree to follow the restrictions on concomitant treatments. * Agree to follow the restrictions on lifestyle (especially regarding physical activity). * Agree to use acceptable contraceptive methods. * Have suitable veins for repeated venipuncture as deemed by the investigator. * Have maintained consistent dietary habits (including medication and supplement intake), exercise and lifestyle habits for the last 3 months before screening (Visit 1A) and agree to maintain them throughout the study (unless required per the restrictions). * Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures. Exclusion Criteria: * Individuals who are lactating, planning to become pregnant during the study, or pregnancy as confirmed by a positive urine pregnancy test at screening Visit 1A or Visit 2. * Have a positive drug screen for any of the compounds listed as confirmed at screening Visit 1A or Visit 2. * Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or the rescue medication, NARCAN® (naloxone). * Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis). * Have exercised regularly (generally \> 150 cumulative minutes per week) for 6 months prior to screening (Visit 1A) and/or Visit 2. * Have engaged in regular lower extremity fitness activities (e.g., running, cycling, soccer or hockey) for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening (Visit 1A) and/or Visit 2. * Had lower body surgery (e.g., hips, knees, ankles, etc.) within 6 months prior to screening (Visit 1A) and/or planned lower body surgery during the study. * History of any lower body injury \[e.g., partial anterior cruciate ligament (ACL) tear, broken or fractured bone, major sprain\] within 6 months prior to screening (Visit 1A) and/or during the study. * Have Type I/Type II diabetes or thyroid disease. * Have uncontrolled or controlled high blood pressure (≥140 systolic or ≥90 diastolic mmHg) at screening. * Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency). * Have a history of heart/cardiovascular disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS). * Have active asthma or have experienced an asthma attack in the last 5 years. * Have a history of neurological disorders such as epilepsy. * Have hepatic or renal dysfunction as evidenced by ALT and/or AST being ≥ 2 times the upper limit of normal (ULN), serum creatinine or urea value ≥ 1.5 times the ULN, or other clinically significant abnormal clinical laboratory value per investigator discretion. * Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit. * Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). * Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes. * Reports a clinically significant illness during the 28 days before the first dose of study product. * Major surgery in 3 months prior to screening or planned major surgery during the study. * Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to Visit 2 or a blood donation of more than 450 mL within 56 days prior to Visit 2. * Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2. * Have a history of alcohol or substance abuse in the 12 months prior to Visit 1A (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that to the opinion of the investigator may be of a concern for the study. * Currently consumes more than 2 standard alcoholic beverages per day on average for 4 weeks prior to Visit 1A. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine or 1.5 ounces of liquor. * Evidence of addictive tendency as indicated by an LDQ score ≥ 21 at Visit 1A. * Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before Visit 1A or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study. * Living in the same household as another currently/previously enrolled participant in the present study. * Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.