A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Kava Dietary Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kava Pharmacokinetics Group<br>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<br>* Participants will be given three 75mg kava capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to kava excretion | length of time that it takes for kava to leave the body as measured by serum levels of kava and its metabolites | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kava, dietary supplement, anxiety, generalized anxiety disorder (GAD)