Status:
COMPLETED
A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Thorne HealthTech, Inc
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 d...
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. So...
Eligibility Criteria
Inclusion
- Provide informed consent
- Females of potential childbearing status must use adequate contraceptive precautions
Exclusion
- 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
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03843502
Start Date
February 26 2020
End Date
July 13 2021
Last Update
June 12 2024
Active Locations (1)
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1
UF CTSI Clinical Research Center
Gainesville, Florida, United States, 32610