Trial Outcomes & Findings for Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects (NCT NCT03296800)
NCT ID: NCT03296800
Last Updated: 2021-07-01
Results Overview
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Up to 48 hours
Results posted on
2021-07-01
Participant Flow
Participant milestones
| Measure |
Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid
Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg, bid.
|
Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin
Subjects were dosed with bexagliflozin tablets, 20 mg, qd and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.
|
Bexagliflozin, Then Verapamil and Bexagliflozin
Subjects were dosed with bexagliflozin tablets, 20 mg, and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a bexagliflozin tablet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Bexagliflozin, Then Verapamil and Bexagliflozin
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 10.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Weight
|
81.3 kg
STANDARD_DEVIATION 10.59 • n=5 Participants
|
74.1 kg
STANDARD_DEVIATION 11.31 • n=7 Participants
|
78.9 kg
STANDARD_DEVIATION 9.21 • n=5 Participants
|
78.7 kg
STANDARD_DEVIATION 10.57 • n=4 Participants
|
|
Height
|
170.9 cm
STANDARD_DEVIATION 8.28 • n=5 Participants
|
169.2 cm
STANDARD_DEVIATION 8.38 • n=7 Participants
|
172.1 cm
STANDARD_DEVIATION 10.17 • n=5 Participants
|
170.7 cm
STANDARD_DEVIATION 8.88 • n=4 Participants
|
|
BMI
|
27.8 kg/m^2
STANDARD_DEVIATION 2.73 • n=5 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 3.31 • n=7 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 2.46 • n=5 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 3.50 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hoursWhole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Outcome measures
| Measure |
Study 1: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rifampin
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
Cmax (Maximum Observed Plasma Concentration)
|
161.675 ng/mL
Geometric Coefficient of Variation 28.673
|
193.366 ng/mL
Geometric Coefficient of Variation 22.098
|
97.811 ng/mL
Geometric Coefficient of Variation 53.903
|
117.001 ng/mL
Geometric Coefficient of Variation 60.097
|
159.355 ng/mL
Geometric Coefficient of Variation 35.396
|
169.000 ng/mL
Geometric Coefficient of Variation 24.727
|
PRIMARY outcome
Timeframe: Up to 48 hoursWhole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Outcome measures
| Measure |
Study 1: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rifampin
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
Tmax (Time of Maximum Observed Plasma Concentration)
Bexagliflozin alone
|
2.000 hours
Interval 2.0 to 4.0
|
2.000 hours
Interval 2.0 to 4.083
|
3.0 hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
|
Tmax (Time of Maximum Observed Plasma Concentration)
Bexagliflozin + additional drug
|
3.000 hours
Interval 2.0 to 4.017
|
2.000 hours
Interval 1.017 to 4.0
|
3.000 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 48 hoursWhole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Outcome measures
| Measure |
Study 1: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rifampin
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
T1/2 (Apparent Terminal Elimination Half-life)
Bexagliflozin alone
|
12.090 hours
Geometric Coefficient of Variation 35.950
|
12.190 hours
Geometric Coefficient of Variation 36.966
|
10.709 hours
Geometric Coefficient of Variation 44.103
|
—
|
—
|
—
|
|
T1/2 (Apparent Terminal Elimination Half-life)
Bexagliflozin + additional drug
|
13.894 hours
Geometric Coefficient of Variation 24.806
|
5.318 hours
Geometric Coefficient of Variation 49.740
|
11.675 hours
Geometric Coefficient of Variation 48.222
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 48 hoursPopulation: AUC0-t (from time 0 to time T) was used instead of AUC0-inf for Study 2 since AUC0-inf was not reported
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Outcome measures
| Measure |
Study 1: Bexagliflozin Alone
n=15 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rifampin
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
|
1118.741 hr*ng/mL
Geometric Coefficient of Variation 23.290
|
1583.188 hr*ng/mL
Geometric Coefficient of Variation 23.676
|
698.254 hr*ng/mL
Geometric Coefficient of Variation 43.945
|
601.334 hr*ng/mL
Geometric Coefficient of Variation 49.870
|
1025.101 hr*ng/mL
Geometric Coefficient of Variation 25.746
|
1003.931 hr*ng/mL
Geometric Coefficient of Variation 21.571
|
SECONDARY outcome
Timeframe: 0 to 48 hoursPopulation: Only subjects with data in the specific category is included
Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics.
Outcome measures
| Measure |
Study 1: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rifampin
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
n=16 Participants
Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
n=16 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
Urinary Glucose Excretion 0-48 hr
Pre-dose (-12 - 0 hours)
|
0.02 g
Standard Deviation 0.024
|
0.47 g
Standard Deviation 1.160
|
0.02 g
Standard Deviation 0.014
|
0.12 g
Standard Deviation 0.180
|
0.02 g
Standard Deviation 0.018
|
1.37 g
Standard Deviation 1.476
|
|
Urinary Glucose Excretion 0-48 hr
0 - 12 hours post-dose
|
25.04 g
Standard Deviation 5.579
|
25.90 g
Standard Deviation 5.214
|
31.50 g
Standard Deviation 9.272
|
31.40 g
Standard Deviation 7.363
|
31.14 g
Standard Deviation 5.814
|
31.46 g
Standard Deviation 14.835
|
|
Urinary Glucose Excretion 0-48 hr
12 - 24 hours post-dose
|
21.28 g
Standard Deviation 7.347
|
20.92 g
Standard Deviation 4.358
|
19.43 g
Standard Deviation 6.863
|
15.72 g
Standard Deviation 7.259
|
22.30 g
Standard Deviation 3.933
|
20.51 g
Standard Deviation 5.940
|
|
Urinary Glucose Excretion 0-48 hr
24 - 36 hours post-dose
|
22.04 g
Standard Deviation 7.136
|
22.10 g
Standard Deviation 6.826
|
21.51 g
Standard Deviation 7.668
|
16.32 g
Standard Deviation 6.370
|
24.54 g
Standard Deviation 6.517
|
20.94 g
Standard Deviation 6.745
|
|
Urinary Glucose Excretion 0-48 hr
36 - 48 hours post-dose
|
11.15 g
Standard Deviation 5.447
|
9.53 g
Standard Deviation 3.114
|
6.99 g
Standard Deviation 3.440
|
3.41 g
Standard Deviation 2.318
|
11.31 g
Standard Deviation 4.997
|
4.78 g
Standard Deviation 2.941
|
|
Urinary Glucose Excretion 0-48 hr
0 - 24 hours post-dose
|
47.73 g
Standard Deviation 9.125
|
46.82 g
Standard Deviation 8.530
|
50.93 g
Standard Deviation 15.606
|
47.12 g
Standard Deviation 13.790
|
53.44 g
Standard Deviation 8.712
|
51.97 g
Standard Deviation 13.658
|
|
Urinary Glucose Excretion 0-48 hr
0 - 48 hours post-dose
|
81.67 g
Standard Deviation 16.083
|
78.44 g
Standard Deviation 15.653
|
79.43 g
Standard Deviation 24.490
|
66.86 g
Standard Deviation 19.564
|
89.29 g
Standard Deviation 16.461
|
77.69 g
Standard Deviation 16.497
|
Adverse Events
Study 1: Bexagliflozin Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 1: Bexagliflozin and Probenecid
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Study 2: Bexagliflozin Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 2: Bexagliflozin and Rrifampin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 3: Bexagliflozin Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Study 3: Bexagliflozin and Verapamil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study 1: Bexagliflozin Alone
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
|
Study 1: Bexagliflozin and Probenecid
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Probenecid: Probenecid tablets, 500 mg; bid
|
Study 2: Bexagliflozin Alone
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
|
Study 2: Bexagliflozin and Rrifampin
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Rifampin: Rifampin 600 mg (2 x 300 mg capsules); qd
|
Study 3: Bexagliflozin Alone
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
|
Study 3: Bexagliflozin and Verapamil
n=16 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg; qd
Verapamil: Verapamil hydrochloride tablets, 120 mg; qd
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
6.2%
1/16 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
6.2%
1/16 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
6.2%
1/16 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
6.2%
1/16 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
0.00%
0/16 • The adverse event data were collected from Day 0 up to Day 7 for study 1, Day 0 up to Day 8 for study 2 and Day 0 up to Day 6 for study 3 after drug administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator has no right to publish the trial results.
- Publication restrictions are in place
Restriction type: OTHER