Pharmacokinetics of Kava and Kratom Alone and in Combination

NCT07583407 | Recruiting

• 1 other identifier: B05-25-04-T0091
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate how different formulations of the Feel Free® Tonic containing Kava, Kratom, or a combination of both are processed in the body in healthy adults. The goal is to compare the pharmacokinetic profiles and safety of the combined herbal formulation with Kava alone and Kratom alone to better understand how these ingredients behave when taken individually versus together.

Conditions

Pharmacokinetics; Herb-Herb Interaction

Keywords

Kava; Kratom; Pharmacokinetics; Healthy Adults; Herbal Supplement

Outcome Measures

Primary Outcomes (4)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Kavain

  AUC0-24 for kavain following single-dose administration of Kava alone or combined Kava and Kratom

  Day 1 and Day 2 of each treatment period (0-24 hours post-dose)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Dihydrokavain

  AUC0-24 for dihydrokavain following single-dose administration of Kava alone or combined Kava and Kratom

  Day 1 and Day 2 of each treatment period (0-24 hours post-dose)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Mitragynine

  AUC0-24 for mitragynine following single-dose administration of Kratom alone or combined Kava and Kratom

  Day 1 and Day 2 of each treatment period (0-24 hours post-dose)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for 7-Hydroxymitragynine

  AUC0-24 for 7-Hydroxymitragynine following single-dose administration of Kratom alone or combined Kava and Kratom

  Day 1 and Day 2 of each treatment period (0-24 hours post-dose)

Secondary Outcomes (48)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC0-72) for Kavain

  Day 1 to Day 4 of each treatment period (0-72 hours post-dose)

• Maximum Observed Plasma Concentration (Cmax) for Kavain

  Day 1 of each treatment period (0-12 hours post-dose)

• Time to Maximum Plasma Concentration (Tmax) for Kavain

  Day 1 and Day 2 of each treatment period (0-24 hours post-dose)

• Terminal Elimination Half-Life (T½) for Kavain

  Day 1 to Day 4 of each treatment period (0-72 hours post-dose)

• Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC0-72) for Dihydrokavain

  Day 1 to Day 4 of each treatment period (0-72 hours post-dose)

Other Outcomes (54)

• Modified Drug Effects Questionnaire (DEQ)

  Days 1 and 14 of each treatment period

• Overall Well Being, Health, and Pain

  Pre-dose Day 1 to Pre-dose Days 7 and 14 of each treatment period

• Ecological Momentary Assessment (EMA) Survey

  Days 2, 4, 6, 8, 10, 12, and 14 of each treatment period

Study Arms (3)

Half- Strength Feel Free Classic Tonic (TP1)

ACTIVE COMPARATOR

Active Product of 380 mg Kava root extract and 1480 mg of dried Kratom Leaf powder per bottle

Dietary Supplement: Kava and Kratom Herbal Supplement

Kava Only Variant - Feel Free Tonic (TP2)

ACTIVE COMPARATOR

Active Product of 380 mg Kava root extract per bottle

Dietary Supplement: Kava Herbal Supplement

Kratom Only Variant - Feel Free Tonic (TP3)

ACTIVE COMPARATOR

Active Product of 1480 mg dried Kratom Leaf powder per bottle

Dietary Supplement: Kratom Herbal Supplement

Interventions

Kava and Kratom Herbal Supplement DIETARY_SUPPLEMENT

Half- Strength Feel Free Classic Tonic (TP1)

Half- Strength Feel Free Classic Tonic (TP1)

Kava Herbal Supplement DIETARY_SUPPLEMENT

Kava Only Variant - Feel Free Tonic (TP2)

Kava Only Variant - Feel Free Tonic (TP2)

Kratom Herbal Supplement DIETARY_SUPPLEMENT

Kratom Only Variant - Feel Free Tonic (TP3)

Kratom Only Variant - Feel Free Tonic (TP3)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults who are between 21 - 55 years of age (inclusive) at the time of signing the informed consent.
• In otherwise good general health, 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).
• Are able to consume the study product completely within the specified timeframe.
• 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.
• Have a BMI range of 18.5 - 29.9 kg/m2 at screening and Visit 2.
• Agree to follow the restrictions on concomitant treatments.
• Agree to follow the restrictions on lifestyle.
• 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 (unless required per the restrictions)
• Individuals with childbearing potential must agree to comply with the following requirements:
• Have a negative pregnancy test at screening and on Day 1 of each treatment period prior to administration of study product.
• Use a highly effective method of contraception from at least 14 days prior to the first dose through 30 days after the last dose of study product.
• Individuals with the potential to impregnate others must agree to use a highly effective method of contraception, from at least 14 days prior to the first dose through 30 days after the last dose of study product.
• Male-born participants must agree to abstain from sperm donation, and female-born participants must agree to abstain from ovum donation, from Screening through at least 30 days after the last dose of study product.
• Agree to abstain from alcohol consumption for 48 hours prior to, and for the entire duration of, each treatment period.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
• Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
• Demonstrates a positive urine drug screen test for compounds listed in Table 8 4 at the Screening Visit or Visit 2, a positive urine cotinine test at the Screening Visit or Visit 2, or a positive breath alcohol test at Screening Visit or Visit 2.
• Have abnormal respiratory rate (RR) or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
• Screening laboratory results showing liver enzyme levels \[Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin\] ≥ 2 times the upper limit of normal (ULN), or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.
• Have hemoglobin below 135 g/L for males or 125 g/L for females, or hematocrit below 0.39 l/l for males or 0.33 l/l for females at screening.
• Demonstrates a positive screen for HIV at screening.
• Is currently enrolled in another clinical trial or has received/used an investigational product in another research study within 28 days before Visit 2.
• Individuals with any abnormality, obstruction, or disorder of the gastrointestinal tract that may preclude swallowing (e.g., dysphagia) or impair gastrointestinal motility, digestion, or absorption (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease \[including Crohn's disease or ulcerative colitis\], chronic pancreatitis, or steatorrhea). In addition, any history of gastrointestinal surgery or anatomical abnormality that, in the opinion of the Investigator, may affect the oral absorption of the study product.
• Have been diagnosed with Type I/Type II diabetes or thyroid disease
• High BP at the Screening Visit or Visit 2 (≥140 systolic or ≥90 diastolic mmHg)
• Have low BP (\<90 systolic or \<60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.
• Have a history of heart disease, blood-clotting disorders, renal or hepatic impairment/disease, liver injury or any clinically significant liver or kidney disorder, as determined by the Investigator.
• Have known genetic polymorphisms of CYP450 enzymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2B6, and/or CYP3A4.
• Individuals with active asthma or a history of clinically significant asthma exacerbation (i.e., requiring systemic corticosteroids, emergency department intervention, or hospitalization) within the past 12 months.

Sponsors & Collaborators

• Botanic Tonics, LLC: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

ApexTrials

Guelph, Ontario, N1G 0B4, Canada

RECRUITING

Study Officials

• Ramsey Atallah

  Botanic Tonics

  STUDY DIRECTOR

Central Study Contacts

Ambreen Atif, MD

CONTACT

519-341-3367; aatif@nutrasource.ca

Stephanie Recker

CONTACT

519-341-3367; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 13, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)