Pharmacokinetics study in healthy adults Other
Conditions
Interventions
Study Duration: The entire study duration for each participant in each arm is approximately 3-8 weeks.
a. Screening period up to 28 days
b. 2 PK visits per test period (Periods A and B
PK Day 1 is approximately 14 hours
PK Day 2 is approximately 1 hour)
c. A washout period between test periods of 14 to 24 days
Follow-up Duration: The study is considered completed at the last study visit for the last participant or 30
Sponsors
Botanic Tonics, LLC
Eligibility
Sex/Gender
All
Age
21 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Adults who are 21 to 55 years of age (inclusive). 2. In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator (based on review of medical history, vital signs, laboratory safety tests, and physical examination performed at screening and/or before the first dose of study product). 3. Are able to consume the study product completely within the specified timeframe. 4. Not currently using, defined as = 3 uses in the past 3 months prior to Visit 2, any nicotine-containing products (patches, gums, vapes, etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Visit 2 and throughout the study. 5. Have a BMI between 18.5 to 29.9 kg/m² (inclusive) and a body weight of = 50 kg at screening and baseline (Visit 2). 6. Agree not to donate blood until 3 months after the study completion. 7. Must have suitable veins for repeated venipuncture. 8. Have maintained consistent dietary habits, including supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study. 9. Agree to follow the restrictions on concomitant treatments 10. Agree to follow the restrictions on lifestyle 11. Agree to use acceptable contraceptive methods 12. Willing and able to agree to the requirements of this study, be willing to give voluntary consent, and carry out all study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Individuals who are lactating, pregnant, or planning to become pregnant during the study or demonstrate a positive pregnancy test at Visits 1 or 2. 2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients. 3. Demonstrates a positive urine drug screen test at Visits 1 or 2, a positive urine cotinine test at Visit 2, or a positive breath alcohol test at Visit 2. 4. Individuals with an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). 5. Screening laboratory results showing liver enzyme levels [Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin] that are = 2 times the upper limit of normal, or any other clinically significant abnormal safety laboratory values as per the Investigator’s discretion. 6. Have Type I/II diabetes, high (=140 systolic or =90 diastolic mmHg) or low (<90 systolic or <60 diastolic mmHg) BP at Visit 2, or thyroid disease. 7. Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, seizure disorders, epilepsy, or neurological disease. 8. Have known genetic polymorphisms of CYP450 enzymes, including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2B6, and/or CYP3A4. 9. 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). 10. 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. 11. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). 12. Reports significant blood loss or blood donation totaling between 101 mL and 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. 13. Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2. 14. Major surgery in the 3 months prior to screening or planned major surgery during the study. 15. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an inpatient or outpatient intervention program) or use that, in the opinion of the investigator, may be of a concern for the study. 16. Currently consumes more than 2 standard alcoholic beverages a day. Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor. 17. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before the first dose of study product 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 the current study. 18. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC0–t) for kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 2. Maximum plasma concentration (Cmax) of kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 3. Time to reach maximum plasma concentration (Tmax) of kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 4. Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 5. Terminal elimination half-life (T½) of kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 6. Elimination rate constant (Kel) of kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcome measures: 1. Systolic and diastolic blood pressure is measured using automated sphygmomanometer at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 2. Heart rate is measured using automated sphygmomanometer at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 3. Haematology parameters are measured using standard full blood count panel at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 4. Clinical chemistry parameters are measured using standard biochemistry panel at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 5. Liver function parameters are measured using standard liver function test panel at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 6. Renal function parameters are measured using standard renal function test panel at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET 7. Adverse events are measured using spontaneous participant report and investigator assessment at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5/ET | — |
Countries
Canada
Contacts
Public ContactCaroline Crudeli Sclearuc Haiashi
Outcome results
None listed