Trial Outcomes & Findings for A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics (NCT NCT03843502)
NCT ID: NCT03843502
Last Updated: 2024-06-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
pre-dose to 12 hours post-dose
Results posted on
2024-06-12
Participant Flow
Individuals were recruitment for this study via flyers placed in various location in and around the Gainesville area.
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics
Baseline characteristics by cohort
| Measure |
Kava Pharmacokinetics Single Dose Group
n=5 Participants
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.
|
Kava Pharmacokinetics 3x a Day Dose Group
n=5 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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21 years
n=5 Participants
|
21 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose to 12 hours post-dosePopulation: 10 healthy participants were included in the analysis
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
Outcome measures
| Measure |
Kava Pharmacokinetics Single Dose Group
n=5 Participants
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.
|
Kava Pharmacokinetics 3x a Day Dose Group
n=5 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
|
|---|---|---|
|
Time to Maximum Concentration of Kava in the Blood
Kavain
|
1.9 hours
Standard Error 1.1
|
1.2 hours
Standard Error 0.8
|
|
Time to Maximum Concentration of Kava in the Blood
Dihydrokavain
|
1.3 hours
Standard Error 0.9
|
1.2 hours
Standard Error 0.8
|
|
Time to Maximum Concentration of Kava in the Blood
Methysticin
|
1.9 hours
Standard Error 1.1
|
1.2 hours
Standard Error 0.8
|
|
Time to Maximum Concentration of Kava in the Blood
Dihydromethysticin
|
1.5 hours
Standard Error 1.0
|
1.20 hours
Standard Error 0.8
|
|
Time to Maximum Concentration of Kava in the Blood
Yangonin
|
1.9 hours
Standard Error 0.9
|
1.8 hours
Standard Error 0.8
|
Adverse Events
Kava Pharmacokinetics Single Dose Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Kava Pharmacokinetics 3x a Day Dose Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kava Pharmacokinetics Single Dose Group
n=5 participants at risk
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.
|
Kava Pharmacokinetics 3x a Day Dose Group
n=5 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching two days post dose
|
0.00%
0/5 • 11 months
Reporting information follows clinicaltrials.gov guidelines
|
20.0%
1/5 • Number of events 1 • 11 months
Reporting information follows clinicaltrials.gov guidelines
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place