Phase 1 N=10 Basic Science

A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

Pharmacokinetics

Bottom Line

View on ClinicalTrials.gov: NCT03843502 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Time to Maximum Concentration of Kava in the Blood — 1.9; 1.2; 1.3; 1.2 hours

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Kava Dietary Supplement (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Maximum Concentration of Kava in the Blood	1.9; 1.2; 1.3; 1.2; 1.9; 1.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03843502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.