Trial Outcomes & Findings for Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience (NCT NCT06072170)
NCT ID: NCT06072170
Last Updated: 2025-09-29
Results Overview
For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 1 through Day 7
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Cohort 1, 1 g of Kratom
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
Baseline characteristics by cohort
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 3.54 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 6.89 • n=4 Participants
|
40.2 years
STANDARD_DEVIATION 6.40 • n=21 Participants
|
32.5 years
STANDARD_DEVIATION 4.81 • n=8 Participants
|
36.3 years
STANDARD_DEVIATION 7.38 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Body Mass Index
|
24.02 kg/m2
STANDARD_DEVIATION 4.279 • n=5 Participants
|
26.82 kg/m2
STANDARD_DEVIATION 4.222 • n=7 Participants
|
27.42 kg/m2
STANDARD_DEVIATION 4.901 • n=5 Participants
|
25.85 kg/m2
STANDARD_DEVIATION 2.811 • n=4 Participants
|
24.33 kg/m2
STANDARD_DEVIATION 2.277 • n=21 Participants
|
25.48 kg/m2
STANDARD_DEVIATION 4.132 • n=8 Participants
|
25.64 kg/m2
STANDARD_DEVIATION 3.835 • n=8 Participants
|
|
Weight (kg)
|
73.78 kg
STANDARD_DEVIATION 14.910 • n=5 Participants
|
84.83 kg
STANDARD_DEVIATION 14.552 • n=7 Participants
|
79.60 kg
STANDARD_DEVIATION 13.565 • n=5 Participants
|
80.08 kg
STANDARD_DEVIATION 12.090 • n=4 Participants
|
74.62 kg
STANDARD_DEVIATION 9.338 • n=21 Participants
|
74.51 kg
STANDARD_DEVIATION 12.946 • n=8 Participants
|
77.56 kg
STANDARD_DEVIATION 12.787 • n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0).
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
Cmax (ng/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration
Mitragynine
|
41.664 ng/mL
Standard Deviation 14.766
|
118.002 ng/mL
Standard Deviation 46.816
|
197.496 ng/mL
Standard Deviation 88.333
|
318.112 ng/mL
Standard Deviation 163.400
|
378.507 ng/mL
Standard Deviation 184.981
|
—
|
|
Maximum Observed Concentration
7 hydroxy-mitragynine
|
6.728 ng/mL
Standard Deviation 2.182
|
17.751 ng/mL
Standard Deviation 8.687
|
33.985 ng/mL
Standard Deviation 11.184
|
48.388 ng/mL
Standard Deviation 19.989
|
58.400 ng/mL
Standard Deviation 22.717
|
—
|
|
Maximum Observed Concentration
Paynantheine
|
7.7 ng/mL
Standard Deviation 2.6
|
19.0 ng/mL
Standard Deviation 5.0
|
29.7 ng/mL
Standard Deviation 14.6
|
66.7 ng/mL
Standard Deviation 36.6
|
65.8 ng/mL
Standard Deviation 34.2
|
—
|
|
Maximum Observed Concentration
Speciogynine
|
6.3 ng/mL
Standard Deviation 1.9
|
15.8 ng/mL
Standard Deviation 4.3
|
23.2 ng/mL
Standard Deviation 10.1
|
58.9 ng/mL
Standard Deviation 35.5
|
55.5 ng/mL
Standard Deviation 31.0
|
—
|
|
Maximum Observed Concentration
Speciociliatine
|
39.1 ng/mL
Standard Deviation 11.7
|
106.6 ng/mL
Standard Deviation 23.9
|
168.9 ng/mL
Standard Deviation 68.1
|
388.1 ng/mL
Standard Deviation 217.2
|
409.7 ng/mL
Standard Deviation 193.8
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
Tmax (hours) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Time of Maximum Observed Concentration
7 hydroxy-mitragynine
|
4.02 hours
Interval 2.5 to 6.18
|
3.50 hours
Interval 2.99 to 4.0
|
6.01 hours
Interval 3.0 to 10.02
|
4.00 hours
Interval 3.0 to 4.0
|
2.75 hours
Interval 1.5 to 6.01
|
—
|
|
Time of Maximum Observed Concentration
mitragynine
|
4.02 hours
Interval 2.5 to 6.18
|
2.99 hours
Interval 2.5 to 4.0
|
5.04 hours
Interval 2.5 to 6.14
|
3.50 hours
Interval 2.5 to 4.0
|
2.00 hours
Interval 1.0 to 6.01
|
—
|
|
Time of Maximum Observed Concentration
paynantheine
|
4.02 hours
Interval 2.5 to 6.18
|
2.99 hours
Interval 2.5 to 4.0
|
5.04 hours
Interval 3.0 to 6.14
|
3.00 hours
Interval 2.5 to 4.0
|
3.29 hours
Interval 1.5 to 6.01
|
—
|
|
Time of Maximum Observed Concentration
speciogynine
|
4.02 hours
Interval 2.5 to 6.18
|
3.00 hours
Interval 2.99 to 4.0
|
5.04 hours
Interval 3.0 to 10.02
|
4.00 hours
Interval 3.0 to 6.0
|
2.54 hours
Interval 1.5 to 6.01
|
—
|
|
Time of Maximum Observed Concentration
speciociliatine
|
4.02 hours
Interval 3.0 to 8.04
|
5.00 hours
Interval 3.0 to 9.99
|
8.07 hours
Interval 3.0 to 12.0
|
5.00 hours
Interval 4.0 to 8.0
|
5.06 hours
Interval 2.0 to 10.01
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
AUC0-T (ng\*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)
mitragynine
|
305.383 ng*h/mL
Standard Deviation 115.616
|
784.794 ng*h/mL
Standard Deviation 380.290
|
1942.205 ng*h/mL
Standard Deviation 737.483
|
3254.385 ng*h/mL
Standard Deviation 2213.450
|
3271.209 ng*h/mL
Standard Deviation 1577.443
|
—
|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)
7 hydroxy-mitragynine
|
53.518 ng*h/mL
Standard Deviation 21.615
|
132.994 ng*h/mL
Standard Deviation 85.838
|
412.602 ng*h/mL
Standard Deviation 153.549
|
459.109 ng*h/mL
Standard Deviation 226.314
|
574.260 ng*h/mL
Standard Deviation 194.789
|
—
|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)
speciociliatine
|
573.9 ng*h/mL
Standard Deviation 285.4
|
1910.9 ng*h/mL
Standard Deviation 475.4
|
3359.2 ng*h/mL
Standard Deviation 1257.7
|
7904.8 ng*h/mL
Standard Deviation 4790.9
|
7449.8 ng*h/mL
Standard Deviation 3695.4
|
—
|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)
paynantheine
|
47.0 ng*h/mL
Standard Deviation 19.0
|
132.9 ng*h/mL
Standard Deviation 44.0
|
320.2 ng*h/mL
Standard Deviation 134.0
|
725.2 ng*h/mL
Standard Deviation 452.4
|
727.6 ng*h/mL
Standard Deviation 397.9
|
—
|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-T)
speciogynine
|
53.4 ng*h/mL
Standard Deviation 19.2
|
154.0 ng*h/mL
Standard Deviation 44.1
|
341.0 ng*h/mL
Standard Deviation 147.5
|
819.2 ng*h/mL
Standard Deviation 521.6
|
790.0 ng*h/mL
Standard Deviation 453.2
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
AUC0-inf (ng\*h/mL) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Extrapolated to Infinity
mitragynine
|
341.941 ng*h/mL
Standard Deviation 131.703
|
897.401 ng*h/mL
Standard Deviation 436.438
|
2305.048 ng*h/mL
Standard Deviation 1068.794
|
3950.438 ng*h/mL
Standard Deviation 2839.536
|
3674.606 ng*h/mL
Standard Deviation 1790.980
|
—
|
|
Area Under the Concentration Time Curve Extrapolated to Infinity
7 hydroxy-mitragynine
|
57.023 ng*h/mL
Standard Deviation 21.974
|
139.322 ng*h/mL
Standard Deviation 88.492
|
438.569 ng*h/mL
Standard Deviation 169.329
|
515.160 ng*h/mL
Standard Deviation 284.275
|
596.489 ng*h/mL
Standard Deviation 206.138
|
—
|
|
Area Under the Concentration Time Curve Extrapolated to Infinity
paynantheine
|
58.3 ng*h/mL
Standard Deviation 22.6
|
160.1 ng*h/mL
Standard Deviation 52.6
|
380.3 ng*h/mL
Standard Deviation 161.2
|
819.4 ng*h/mL
Standard Deviation 477.5
|
814.8 ng*h/mL
Standard Deviation 462.9
|
—
|
|
Area Under the Concentration Time Curve Extrapolated to Infinity
speciogynine
|
76.1 ng*h/mL
Standard Deviation 27.5
|
190.1 ng*h/mL
Standard Deviation 51.1
|
413.2 ng*h/mL
Standard Deviation 189.8
|
958.6 ng*h/mL
Standard Deviation 570.7
|
906.3 ng*h/mL
Standard Deviation 544.4
|
—
|
|
Area Under the Concentration Time Curve Extrapolated to Infinity
speciociliatine
|
654.9 ng*h/mL
Standard Deviation 377.1
|
2099.8 ng*h/mL
Standard Deviation 578.7
|
4187.3 ng*h/mL
Standard Deviation 1567.2
|
8908.0 ng*h/mL
Standard Deviation 5130.1
|
8012.7 ng*h/mL
Standard Deviation 4075.7
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
Cmax/D (ng/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Dose-normalized Cmax Calculated at Cmax / Dose
paynantheine
|
7.7 ng/mL/g
Standard Deviation 2.6
|
6.3 ng/mL/g
Standard Deviation 1.7
|
3.7 ng/mL/g
Standard Deviation 1.8
|
6.7 ng/mL/g
Standard Deviation 3.7
|
5.5 ng/mL/g
Standard Deviation 2.8
|
—
|
|
Dose-normalized Cmax Calculated at Cmax / Dose
speciogynine
|
6.3 ng/mL/g
Standard Deviation 1.9
|
5.2 ng/mL/g
Standard Deviation 1.4
|
2.9 ng/mL/g
Standard Deviation 1.3
|
5.9 ng/mL/g
Standard Deviation 3.5
|
4.6 ng/mL/g
Standard Deviation 2.6
|
—
|
|
Dose-normalized Cmax Calculated at Cmax / Dose
speciociliatine
|
39.1 ng/mL/g
Standard Deviation 11.7
|
35.5 ng/mL/g
Standard Deviation 8.0
|
21.1 ng/mL/g
Standard Deviation 8.5
|
38.8 ng/mL/g
Standard Deviation 21.7
|
34.1 ng/mL/g
Standard Deviation 16.2
|
—
|
|
Dose-normalized Cmax Calculated at Cmax / Dose
mitragynine
|
41.664 ng/mL/g
Standard Deviation 14.766
|
39.334 ng/mL/g
Standard Deviation 15.605
|
24.687 ng/mL/g
Standard Deviation 11.042
|
31.811 ng/mL/g
Standard Deviation 16.340
|
31.542 ng/mL/g
Standard Deviation 15.415
|
—
|
|
Dose-normalized Cmax Calculated at Cmax / Dose
7 hydroxy-mitragynine
|
6.728 ng/mL/g
Standard Deviation 2.182
|
5.917 ng/mL/g
Standard Deviation 2.896
|
4.248 ng/mL/g
Standard Deviation 1.398
|
4.839 ng/mL/g
Standard Deviation 1.999
|
4.867 ng/mL/g
Standard Deviation 1.893
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
AUC0-T/D (ng\*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Dose-normalized AUC0-T Calculated as AUC0-T / Dose
7 hydroxy-mitragynine
|
53.518 ng*h/mL/g
Standard Deviation 21.615
|
44.331 ng*h/mL/g
Standard Deviation 28.613
|
51.575 ng*h/mL/g
Standard Deviation 19.194
|
45.911 ng*h/mL/g
Standard Deviation 22.631
|
47.855 ng*h/mL/g
Standard Deviation 16.232
|
—
|
|
Dose-normalized AUC0-T Calculated as AUC0-T / Dose
mitragynine
|
305.383 ng*h/mL/g
Standard Deviation 115.616
|
261.598 ng*h/mL/g
Standard Deviation 126.763
|
242.776 ng*h/mL/g
Standard Deviation 92.185
|
325.438 ng*h/mL/g
Standard Deviation 221.345
|
272.601 ng*h/mL/g
Standard Deviation 131.454
|
—
|
|
Dose-normalized AUC0-T Calculated as AUC0-T / Dose
paynantheine
|
47.0 ng*h/mL/g
Standard Deviation 19.0
|
44.3 ng*h/mL/g
Standard Deviation 14.7
|
40.0 ng*h/mL/g
Standard Deviation 16.8
|
72.5 ng*h/mL/g
Standard Deviation 45.2
|
60.6 ng*h/mL/g
Standard Deviation 33.2
|
—
|
|
Dose-normalized AUC0-T Calculated as AUC0-T / Dose
speciogynine
|
53.4 ng*h/mL/g
Standard Deviation 19.2
|
51.3 ng*h/mL/g
Standard Deviation 14.7
|
42.6 ng*h/mL/g
Standard Deviation 18.4
|
81.9 ng*h/mL/g
Standard Deviation 52.2
|
65.8 ng*h/mL/g
Standard Deviation 37.8
|
—
|
|
Dose-normalized AUC0-T Calculated as AUC0-T / Dose
speciociliatine
|
573.9 ng*h/mL/g
Standard Deviation 285.4
|
637.0 ng*h/mL/g
Standard Deviation 158.5
|
419.9 ng*h/mL/g
Standard Deviation 157.2
|
790.5 ng*h/mL/g
Standard Deviation 479.1
|
620.8 ng*h/mL/g
Standard Deviation 308.0
|
—
|
SECONDARY outcome
Timeframe: 0, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 48.00 hours post-dosePopulation: Placebo subjects were not included in the PK population.
AUC0-inf/D (ng\*h/mL/g) will be evaluated for: mitragynine, 7 hydroxy-mitragynine, paynantheine, speciogynine, and speciociliatine
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose
mitragynine
|
341.941 (ng*h/mL/g
Standard Deviation 131.703
|
299.134 (ng*h/mL/g
Standard Deviation 145.479
|
288.131 (ng*h/mL/g
Standard Deviation 133.599
|
395.044 (ng*h/mL/g
Standard Deviation 283.954
|
306.217 (ng*h/mL/g
Standard Deviation 149.248
|
—
|
|
Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose
paynantheine
|
58.3 (ng*h/mL/g
Standard Deviation 22.6
|
53.4 (ng*h/mL/g
Standard Deviation 17.5
|
47.5 (ng*h/mL/g
Standard Deviation 20.2
|
81.9 (ng*h/mL/g
Standard Deviation 47.8
|
67.9 (ng*h/mL/g
Standard Deviation 38.6
|
—
|
|
Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose
speciogynine
|
76.1 (ng*h/mL/g
Standard Deviation 27.5
|
63.4 (ng*h/mL/g
Standard Deviation 17.0
|
51.6 (ng*h/mL/g
Standard Deviation 23.7
|
95.9 (ng*h/mL/g
Standard Deviation 57.1
|
75.5 (ng*h/mL/g
Standard Deviation 45.4
|
—
|
|
Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose
speciociliatine
|
654.9 (ng*h/mL/g
Standard Deviation 377.1
|
699.9 (ng*h/mL/g
Standard Deviation 192.9
|
523.4 (ng*h/mL/g
Standard Deviation 195.9
|
890.8 (ng*h/mL/g
Standard Deviation 513.0
|
667.7 (ng*h/mL/g
Standard Deviation 339.6
|
—
|
|
Dose-normalized AUC0-inf Calculated as AUC0-inf / Dose
7 hydroxy-mitragynine
|
57.023 (ng*h/mL/g
Standard Deviation 21.974
|
46.441 (ng*h/mL/g
Standard Deviation 29.497
|
54.821 (ng*h/mL/g
Standard Deviation 21.166
|
51.516 (ng*h/mL/g
Standard Deviation 28.427
|
49.707 (ng*h/mL/g
Standard Deviation 17.178
|
—
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdoseMaximum (peak) effect (Emax) for Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100).
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Effect for Drug Liking
|
50.7 score on a scale (VAS Emax)
Standard Error 0.67
|
51.7 score on a scale (VAS Emax)
Standard Error 1.67
|
60.2 score on a scale (VAS Emax)
Standard Error 8.17
|
52.2 score on a scale (VAS Emax)
Standard Error 0.98
|
68.7 score on a scale (VAS Emax)
Standard Error 9.22
|
50.2 score on a scale (VAS Emax)
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 12 and 24 hours postdoseMaximum (peak) effect (Emax) for Overall Drug Liking assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "strong disliking" (score = 0), "neither like nor dislike" (score = 50) to "strong liking" (score = 100).
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Effect for Overall Drug Liking
|
50.2 score on a scale (VAS EMax)
Standard Error 0.17
|
50 score on a scale (VAS EMax)
Standard Error 0
|
61.8 score on a scale (VAS EMax)
Standard Error 8.37
|
55.7 score on a scale (VAS EMax)
Standard Error 13.22
|
67 score on a scale (VAS EMax)
Standard Error 7.96
|
45.1 score on a scale (VAS EMax)
Standard Error 4.9
|
SECONDARY outcome
Timeframe: 12 and 24 hours postdoseMaximum (peak) effect (Emax) for Take Drug Again assessed on a bipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "definitely would not" (score = 0), "neither would nor would not" (score = 50) to "definitely would" (score = 100).
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Effect for Take Drug Again
|
53.3 score on a scale (VAS EMax)
Standard Error 3.14
|
50.0 score on a scale (VAS EMax)
Standard Error 0
|
65.2 score on a scale (VAS EMax)
Standard Error 8.04
|
49.8 score on a scale (VAS EMax)
Standard Error 17.17
|
61 score on a scale (VAS EMax)
Standard Error 8.57
|
45.9 score on a scale (VAS EMax)
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdoseMaximum (peak) effect (Emax) for High assessed on an unipolar (0 to 100 points) visual analog scale (VAS). Anchors will be presented using text such as "not at all" (score = 0) to "extremely" (score = 100).
Outcome measures
| Measure |
Cohort 1, 1 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 Participants
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 Participants
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Effect for High
|
0.5 score on a scale (VAS EMax)
Standard Error 0.5
|
1.2 score on a scale (VAS EMax)
Standard Error 1.17
|
10.8 score on a scale (VAS EMax)
Standard Error 4.94
|
8.5 score on a scale (VAS EMax)
Standard Error 5.33
|
46.3 score on a scale (VAS EMax)
Standard Error 14.14
|
0.4 score on a scale (VAS EMax)
Standard Error 0.31
|
Adverse Events
Cohort 1, 1 g of Kratom
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2, 3 g of Kratom
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3, 8 g of Kratom
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4, 10 g of Kratom
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5, 12 g of Kratom
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1, 1 g of Kratom
n=6 participants at risk
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 2, 3 g of Kratom
n=6 participants at risk
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 3, 8 g of Kratom
n=6 participants at risk
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 4, 10 g of Kratom
n=6 participants at risk
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Cohort 5, 12 g of Kratom
n=6 participants at risk
A total of 6 subjects will receive an oral single dose administration of the active product
Kratom: Single administration thirty minutes after the start of a high-fat breakfast
|
Placebo
n=10 participants at risk
A total of 2 subjects per cohort will receive an oral single dose administration of placebo
Placebo: Single administration thirty minutes after the start of a high-fat breakfast
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
10.0%
1/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
50.0%
3/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
20.0%
2/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
33.3%
2/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
33.3%
2/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
33.3%
2/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
10.0%
1/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
33.3%
2/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
General disorders
Chills
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
16.7%
1/6 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
0.00%
0/10 • 37 days.
For the purposes of this study, the monitoring period for AEs extends from the pre-trial evaluation until collection of the last blood sample of the study. From screening to dosing of the study, AEs will be recorded as screening events or as part of the medical history, as applicable.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place