A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Pharmacokinetics Clinical Trial

— KavaPK  

Official title:

A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843502
• Other study ID #: IRB201900074 -N
• Secondary ID: OCR202311R61AT00
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 13, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Kava Dietary Supplement
Participants will be given three 75mg kava capsules.

Locations

Country	Name	City	State
United States	UF CTSI Clinical Research Center	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Center for Complementary and Integrative Health (NCCIH), Thorne HealthTech, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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