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| ID | Type | Description | Link |
|---|---|---|---|
| OCR20231 | Other Identifier | OnCore | |
| 1R61AT009988-01A1 | U.S. NIH Grant/Contract | View source | |
| 3R61AT009988-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Thorne HealthTech, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kava Dietary Supplement | Drug | Participants will be given three 75mg kava capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Mathews, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF CTSI Clinical Research Center | Gainesville | Florida | 32610 | United States |
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Any individuals who were found to have a positive urine drug screen, had abnormal lab values, or were found to have active suicidal ideation were excluded from the study prior to baseline.
Individuals were recruitment for this study via flyers placed in various location in and around the Gainesville area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kava Pharmacokinetics Single Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs. |
| FG001 | Kava Pharmacokinetics 3x a Day Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kava Pharmacokinetics Single Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 10 healthy participants were included in the analysis | Posted | Mean | Standard Error | hours | pre-dose to 12 hours post-dose |
|
11 months
Reporting information follows clinicaltrials.gov guidelines
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kava Pharmacokinetics Single Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules in a single dose/timepoint and nine blood draws will be collected over a twelve hour period following administration of kava. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching two days post dose | Skin and subcutaneous tissue disorders | Systematic Assessment | Itching two days post dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Nelson | University of Florida | 3522945563 | r.nelson@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2021 | Apr 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2021 | May 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| BG001 |
| Kava Pharmacokinetics 3x a Day Dose Group |
5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs |
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|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Kava Pharmacokinetics 3x a Day Dose Group | 5 subjects will take three 75 mg kava dietary supplement capsules split among three time points during the study visit. Nine blood draws will be collected over a twelve hour study period. Kava Dietary Supplement: Participants will be given three 75mg kava capsules for a total dose of 225mgs | 0 | 5 | 0 | 5 | 1 | 5 |
|
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