A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

NCT03843502 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB201900074 -NOCR202311R61AT009988-01A13R61AT009988-02S1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

kava; dietary supplement; anxiety; generalized anxiety disorder (GAD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Kava Pharmacokinetics Group

EXPERIMENTAL

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

Interventions

Kava Dietary Supplement DRUG

Participants will be given three 75mg kava capsules.

Also known as: Kava metabolites

Kava Pharmacokinetics Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Thorne HealthTech, Inc: collaborator

Study Sites (1)

UF CTSI Clinical Research Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Robyn Nelson
• Organization: University of Florida

r.nelson@ufl.edu

3522945563

Study Officials

• Carol Mathews, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 18, 2019
• Study Start: February 26, 2020
• Primary Completion: April 21, 2021
• Study Completion: July 13, 2021
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)