Clinical trial NCT03843502: A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Official title: A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: kava
dietary supplement
anxiety
generalized anxiety disorder (GAD)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Thorne HealthTech, Inc
First posted: 2019-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Time to Maximum Concentration of Kava in the Blood
timeFrame: pre-dose to 12 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF CTSI Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Carol Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References: