A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Kava Dietary Supplement

• Registration Number: NCT03843502
• Lead Sponsor: University of Florida

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-18
• Study Start: 2020-02-26
• Primary Completion: 2021-04-21
• Study Completion: 2021-07-13
• Results First Submitted: 2024-04-30
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Results First Posted: 2024-06-12
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kava Pharmacokinetics Group	Kava Dietary Supplement	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.

Primary Outcome Measures

Name	Time	Method
Time to Maximum Concentration of Kava in the Blood	pre-dose to 12 hours post-dose	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

Trial Locations

Locations (1)

UF CTSI Clinical Research Center; 🇺🇸 Gainesville, Florida, United States