A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics (KavaPK)

Kava is a dietary supplement on the US market and is experiencing a resurgence of its use. Its pharmacokinetic information, however, is lacking which is important for its future effective usage as a dietary supplement or potentially as a botanical therapeutics. This phased trial, based on the recommendation from NIH, is to collect pharmacokinetic data of kava in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Kava Dietary Supplement

Detailed Description

Kava is used in the South Pacific Islands for relaxation and socialization. It is available in the US as a dietary supplement, and was used in Europe in the 1990s to treat mild to moderate anxiety. Some clinical trials suggested kava's efficacy in treating generalized anxiety disorder (GAD), although a recent meta-analysis was inconclusive. While the mechanisms behind kava's anxiolytic activity are not well-established, its clinical use shows no signs of addiction or withdrawal. Kava thus is a promising and potentially novel anxiolytic with a unique mechanism of action. Although kava has been extensively consumed by humans for centuries, its pharmacokinetics have never been characterized in humans. Such knowledge is essential for its future studies of its anxiolytic potential and dose optimization. This study will characterize kava pharmacokinetics, which will set a solid foundation for its future clinical development. To establish kava pharmacokinetics, each participant will take three 75 mg kava capsules in a single dose and the absorption, distribution, metabolism and excretion of kava will be assessed, corresponding to the pharmacokinetic curve. Serum liver biochemistries will then be monitored for up to three months to test liver function response to kava.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF CTSI Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provide informed consent
• Females of potential childbearing status must use adequate contraceptive precautions

Exclusion Criteria:

• Currently taking any medication or supplement other than vitamins
• Inability to refrain from acetaminophen, alcohol, or other potentially hepatotoxic substances during the study
• Have a history of liver disease or currently have liver disease.
• Elevation in serum ALT, AST, ALP or total bilirubin that reaches clinical significance (as determined by the PI) at screening.
• Have an unstable medical, psychiatric, or neurological condition determined by history taken during the screening visit and a physical examination at the baseline visit.
• Have a positive urine drug screen for substances of abuse.
• Currently using tobacco or nicotine containing products of any form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kava Pharmacokinetics Group; Each subject will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over an eight hour period following adminstration of kava.	Drug: Kava Dietary Supplement; Participants will be given three 75mg kava capsules.; Other Names: Kava metabolites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum Concentration of Kava in the Blood	Number of hours that it takes for kava metabolites to reach the maximum concentration in the blood based on multiple blood draws over a 12 hour period	pre-dose to 12 hours post-dose

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Thorne HealthTech, Inc
• Investigators: Principal Investigator: Carol Mathews, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; dietary supplement; kava; generalized anxiety disorder (GAD)
• Other Study ID Numbers: IRB201900074 -N; OCR20231 (Other Identifier: OnCore); 1R61AT009988-01A1 (U.S. NIH Grant/Contract); 3R61AT009988-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No