A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

NCT ID: NCT03843502

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2021-07-13

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kava Dietary Supplement

Intervention Type: DRUG

Participants will be given three 75mg kava capsules.

Interventions

Kava Dietary Supplement

Participants will be given three 75mg kava capsules.

Intervention Type: DRUG

Other Intervention Names

Kava metabolites

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Thorne HealthTech, Inc

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF CTSI Clinical Research Center

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OCR20231

Identifier Type: OTHER

Identifier Source: secondary_id

1R61AT009988-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R61AT009988-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201900074 -N

Identifier Type: -

Identifier Source: org_study_id