Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects (NCT NCT03809039)
NCT ID: NCT03809039
Last Updated: 2025-12-31
Results Overview
The criteria of Mild, Moderate and Severe are as follows: Mild: The event is transient and easily tolerated by the subject. Moderate: The event causes discomfort and interferes with the subject's general condition. Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-12-31
Participant Flow
6 subjects of Part 1 were selected for Part 2.
Participant milestones
| Measure |
Part 1 and Part 2 Placebo
Single dose
|
Part 1: MT-6345 1 mg
Single dose
|
Part 1: MT-6345 5 mg
Single dose
|
Part 1 and Part 2: MT-6345 20 mg
Single dose
|
Part 1: MT-6345 60 mg
Single dose
|
Part 1: MT-6345 120 mg
Single dose
|
Part 1: MT-6345 240 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
11
|
6
|
6
|
6
|
6
|
4
|
5
|
0
|
0
|
|
Part 1
COMPLETED
|
10
|
6
|
6
|
5
|
6
|
4
|
5
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
1
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
COMPLETED
|
1
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
|
Part 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
Reasons for withdrawal
| Measure |
Part 1 and Part 2 Placebo
Single dose
|
Part 1: MT-6345 1 mg
Single dose
|
Part 1: MT-6345 5 mg
Single dose
|
Part 1 and Part 2: MT-6345 20 mg
Single dose
|
Part 1: MT-6345 60 mg
Single dose
|
Part 1: MT-6345 120 mg
Single dose
|
Part 1: MT-6345 240 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
Withdrawn by study termination
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
Baseline Characteristics
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part 1 Placebo
n=11 Participants
Single dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 3 Placebo
n=2 Participants
Multiple dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
11 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
4 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=47 Participants
|
52 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
4 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=47 Participants
|
52 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
4 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=47 Participants
|
52 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
6 Participants
n=4994 Participants
|
6 Participants
n=62 Participants
|
4 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=47 Participants
|
52 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksThe criteria of Mild, Moderate and Severe are as follows: Mild: The event is transient and easily tolerated by the subject. Moderate: The event causes discomfort and interferes with the subject's general condition. Severe: The event causes considerable interference with the subject's general condition and may be incapacitating.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=4 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=1 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=11 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: Placebo
n=2 Participants
Multiple dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mild, Moderate and Severe Adverse Events
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mild, Moderate and Severe Adverse Events
Mild
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
4 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Mild, Moderate and Severe Adverse Events
Moderate
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MT-6345
|
386.2 ng/mL
Standard Deviation 65.23
|
780.9 ng/mL
Standard Deviation 118.5
|
1522 ng/mL
Standard Deviation 301.7
|
141.0 ng/mL
Standard Deviation 42.39
|
523.8 ng/mL
Standard Deviation 200.7
|
8.219 ng/mL
Standard Deviation 1.414
|
37.37 ng/mL
Standard Deviation 9.471
|
153.3 ng/mL
Standard Deviation 38.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MT-6345
|
1.50 hour
Interval 0.5 to 2.01
|
1.50 hour
Interval 0.5 to 1.5
|
1.50 hour
Interval 1.0 to 1.5
|
2.00 hour
Interval 0.5 to 5.0
|
1.25 hour
Interval 0.5 to 2.0
|
0.75 hour
Interval 0.5 to 1.0
|
1.01 hour
Interval 1.0 to 1.52
|
1.00 hour
Interval 0.5 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Terminal Elimination Half Life (t½) of MT-6345
|
44.38 hour
Standard Deviation 10.76
|
46.03 hour
Standard Deviation 22.76
|
47.43 hour
Standard Deviation 31.58
|
39.46 hour
Standard Deviation 8.96
|
31.09 hour
Standard Deviation 8.69
|
34.89 hour
Standard Deviation 12.54
|
31.83 hour
Standard Deviation 7.16
|
34.99 hour
Standard Deviation 8.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345
|
4050 ng.h/mL
Standard Deviation 888
|
7570 ng.h/mL
Standard Deviation 634
|
15100 ng.h/mL
Standard Deviation 2830
|
1400 ng.h/mL
Standard Deviation 288
|
4200 ng.h/mL
Standard Deviation 938
|
59.6 ng.h/mL
Standard Deviation 12.6
|
342 ng.h/mL
Standard Deviation 89.6
|
1350 ng.h/mL
Standard Deviation 293
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345
|
11100 ng.h/mL
Standard Deviation 2590
|
21500 ng.h/mL
Standard Deviation 8740
|
41200 ng.h/mL
Standard Deviation 20100
|
3590 ng.h/mL
Standard Deviation 1200
|
4200 ng.h/mL
Standard Deviation 938
|
115 ng.h/mL
Standard Deviation 28.6
|
776 ng.h/mL
Standard Deviation 284
|
3060 ng.h/mL
Standard Deviation 1080
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1, Part 2, and on Day 1 in Part 3.
AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345
|
11200 ng.h/mL
Standard Deviation 2640
|
21800 ng.h/mL
Standard Deviation 9300
|
42200 ng.h/mL
Standard Deviation 21200
|
3650 ng.h/mL
Standard Deviation 1200
|
9570 ng.h/mL
Standard Deviation 3530
|
126 ng.h/mL
Standard Deviation 31
|
786 ng.h/mL
Standard Deviation 285
|
3190 ng.h/mL
Standard Deviation 1200
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (Kel) of MT-6345
|
0.0166 /h
Standard Deviation 0.005
|
0.0176 /h
Standard Deviation 0.0072
|
0.0198 /h
Standard Deviation 0.0104
|
0.0182 /h
Standard Deviation 0.0038
|
0.0244 /h
Standard Deviation 0.0096
|
0.0222 /h
Standard Deviation 0.0081
|
0.0226 /h
Standard Deviation 0.0044
|
0.0208 /h
Standard Deviation 0.005
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects in Part 1, Part 2 and on Day 1 in Part 3.
MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Residence Time (MRT) of MT-6345
|
57.3 hour
Standard Deviation 14.5
|
58.3 hour
Standard Deviation 28.6
|
58.8 hour
Standard Deviation 40.6
|
50.3 hour
Standard Deviation 9.52
|
42.5 hour
Standard Deviation 11.9
|
42.1 hour
Standard Deviation 16.6
|
40.8 hour
Standard Deviation 10
|
43.9 hour
Standard Deviation 11.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.
CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of MT-6345
|
5.79 litre per hour
Standard Deviation 2.15
|
6.16 litre per hour
Standard Deviation 2.15
|
7.30 litre per hour
Standard Deviation 4.17
|
5.88 litre per hour
Standard Deviation 1.60
|
6.92 litre per hour
Standard Deviation 2.20
|
8.36 litre per hour
Standard Deviation 1.93
|
6.89 litre per hour
Standard Deviation 1.81
|
7.14 litre per hour
Standard Deviation 2.93
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 2 weeks after dosingPopulation: AUC0-t was not collected, and could not be assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours.Population: PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3.
Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 120 mg
n=4 Participants
Single dose
|
Part 1: MT-6345 240 mg
n=5 Participants
Single dose
|
Part 2: MT-6345 20 mg
n=5 Participants
Single dose
|
Part 3: MT-6345 60 mg
n=6 Participants
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 20 mg
n=6 Participants
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345
|
318 litre(s)
Standard Deviation 82.4
|
314 litre(s)
Standard Deviation 32.2
|
319 litre(s)
Standard Deviation 85.5
|
284 litre(s)
Standard Deviation 32.6
|
280 litre(s)
Standard Deviation 82.4
|
335 litre(s)
Standard Deviation 86.7
|
271 litre(s)
Standard Deviation 60.3
|
286 litre(s)
Standard Deviation 39.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 2 weeks after dosingPopulation: LF was not collected, and could not be assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 weeks after dosingPopulation: RA was not collected, and could not be assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)Population: PKPOP subjects in Part 3.
Ae was measured for MT-6345 for the PKPOP subjects in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
Single dose
|
Part 1: MT-6345 120 mg
Single dose
|
Part 1: MT-6345 240 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
Single dose
|
Part 1: MT-6345 20 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Urinary Excreted Amount of Test Compound (Ae) of MT-6345
Day 10
|
—
|
—
|
—
|
—
|
—
|
0.255 milligram(s)
Standard Deviation 0.102
|
—
|
—
|
—
|
—
|
—
|
|
Urinary Excreted Amount of Test Compound (Ae) of MT-6345
Day 1
|
—
|
—
|
—
|
—
|
—
|
0.160 milligram(s)
Standard Deviation 0.0440
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day)Population: PKPOP subjects in Part 3.
Ae% was measured for MT-6345 for the PKPOP subjects in Part 3.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
Single dose
|
Part 1: MT-6345 120 mg
Single dose
|
Part 1: MT-6345 240 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
Single dose
|
Part 1: MT-6345 20 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345
Day 1
|
—
|
—
|
—
|
—
|
—
|
0.3 percentage of dose
Standard Deviation 0.1
|
—
|
—
|
—
|
—
|
—
|
|
Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345
Day 10
|
—
|
—
|
—
|
—
|
—
|
0.4 percentage of dose
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours)Population: PKPOP subjects in Part 3.
CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated.
Outcome measures
| Measure |
Part 1: MT-6345 60 mg
Single dose
|
Part 1: MT-6345 120 mg
Single dose
|
Part 1: MT-6345 240 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
Part 1: MT-6345 1 mg
n=6 Participants
Single dose
|
Part 1: MT-6345 5 mg
Single dose
|
Part 1: MT-6345 20 mg
Single dose
|
Part 2: MT-6345 20 mg
Single dose
|
Part 3: Placebo
Multiple dose
|
Part 3: MT-6345 60 mg
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLR) of MT-6345
|
—
|
—
|
—
|
—
|
—
|
0.0390 L/h
Standard Deviation 0.0110
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: MT-6345 1 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: MT-6345 5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: MT-6345 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: MT-6345 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: MT-6345 120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: MT-6345 240 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: MT-6345 20 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 3: MT-6345 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Placebo
n=11 participants at risk
Single dose
|
Part 1: MT-6345 1 mg
n=6 participants at risk
Single dose
|
Part 1: MT-6345 5 mg
n=6 participants at risk
Single dose
|
Part 1: MT-6345 20 mg
n=6 participants at risk
Single dose
|
Part 1: MT-6345 60 mg
n=6 participants at risk
Single dose
|
Part 1: MT-6345 120 mg
n=4 participants at risk
Single dose
|
Part 1: MT-6345 240 mg
n=5 participants at risk
Single dose
|
Part 2: Placebo
n=1 participants at risk
Single dose
|
Part 2: MT-6345 20 mg
n=5 participants at risk
Single dose
|
Part 3: Placebo
n=2 participants at risk
Multiple dose
|
Part 3: MT-6345 60 mg
n=6 participants at risk
Multiple dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
33.3%
2/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
General disorders
Medical device site reaction
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
16.7%
1/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
20.0%
1/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
25.0%
1/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
|
Infections and infestations
Fungal skin infections
|
9.1%
1/11 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/4 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/1 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/5 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/2 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
0.00%
0/6 • From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma America, Inc.
Phone: Please e-mail
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER