Trial Outcomes & Findings for A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects (NCT NCT04029090)
NCT ID: NCT04029090
Last Updated: 2026-01-08
Results Overview
The primary outcome endpoint was based on an analysis of the regression relationship between ΔQTcF and the concentration of MCI-186 at matching times post-dose, including adjustment for placebo treatments.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
45 min pre-dose to 24 h post-dose
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
Sequence 1 (Treatment A, Then Treatment C, Then Treatment B)
Participants first received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 2 (Treatment B, Then Treatment A, Then Treatment C)
Participants first received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 3 (Treatment C, Then Treatment B, Then Treatment A)
Participants first received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 (Treatment A, Then Treatment C, Then Treatment B)
Participants first received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 2 (Treatment B, Then Treatment A, Then Treatment C)
Participants first received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 3 (Treatment C, Then Treatment B, Then Treatment A)
Participants first received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Sequence 1 (Treatment A, Then Treatment C, Then Treatment B)
n=9 Participants
Participants first received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 2 (Treatment B, Then Treatment A, Then Treatment C)
n=9 Participants
Participants first received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Sequence 3 (Treatment C, Then Treatment B, Then Treatment A)
n=9 Participants
Participants first received a single intravenous dose of Treatment C as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment B as 1-hour infusion. After 14day post treatment, they then received a single intravenous dose of Treatment A as 1-hour infusion. After 14day post treatment. (Treatment A=60mg of MCI-186, Treatment B=300mg of MCI-186, Treatment C=0.9% w/v saline)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
28.7 years
STANDARD_DEVIATION 10.6 • n=17 Participants
|
33.6 years
STANDARD_DEVIATION 9.8 • n=35 Participants
|
30.5 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
27 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
27 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 45 min pre-dose to 24 h post-dosePopulation: All participants who received 600mg, and 300mg of MCI-186 were included in the analysis. One participant on 300mg was not included due to meeting the exclusion criteria (Protocol Violation). Overall Number of Participants Analyzed was entered as the number at the time of calculation of Cmax.
The primary outcome endpoint was based on an analysis of the regression relationship between ΔQTcF and the concentration of MCI-186 at matching times post-dose, including adjustment for placebo treatments.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186
|
-0.5 ms
Interval -1.5 to 0.5
|
0.5 ms
Interval -1.0 to 1.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 Participants
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Change From Baseline of Heart Rate(HR) by Timepoint
30min
|
0.2 beats per minute
Standard Error 2.90
|
-0.2 beats per minute
Standard Error 2.47
|
0.1 beats per minute
Standard Error 2.59
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
60min
|
0.6 beats per minute
Standard Error 3.21
|
1 beats per minute
Standard Error 3.08
|
0.8 beats per minute
Standard Error 3.02
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
75min
|
1 beats per minute
Standard Error 3.43
|
1.1 beats per minute
Standard Error 3.14
|
1.1 beats per minute
Standard Error 3.26
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
90min
|
0.4 beats per minute
Standard Error 3.17
|
1.8 beats per minute
Standard Error 3.63
|
1.6 beats per minute
Standard Error 3.81
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
105min
|
0.6 beats per minute
Standard Error 3.27
|
3.1 beats per minute
Standard Error 3.55
|
1.8 beats per minute
Standard Error 3.91
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
2hr
|
1.7 beats per minute
Standard Error 3.56
|
3.4 beats per minute
Standard Error 3.24
|
3.4 beats per minute
Standard Error 3.8
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
3hr
|
1.8 beats per minute
Standard Error 4.01
|
4 beats per minute
Standard Error 3.69
|
2.6 beats per minute
Standard Error 3.44
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
4hr
|
2.1 beats per minute
Standard Error 4.28
|
3.8 beats per minute
Standard Error 4.22
|
3.1 beats per minute
Standard Error 4.57
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
6hr
|
7.6 beats per minute
Standard Error 4.69
|
9.3 beats per minute
Standard Error 5.18
|
9.1 beats per minute
Standard Error 4.13
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
8hr
|
8.1 beats per minute
Standard Error 5.44
|
10.2 beats per minute
Standard Error 6.26
|
10.3 beats per minute
Standard Error 7.34
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
12hr
|
7.1 beats per minute
Standard Error 4.8
|
9.1 beats per minute
Standard Error 6.77
|
7.4 beats per minute
Standard Error 5.83
|
|
Change From Baseline of Heart Rate(HR) by Timepoint
24hr
|
1.1 beats per minute
Standard Error 4.52
|
4.6 beats per minute
Standard Error 6.9
|
2.7 beats per minute
Standard Error 4.01
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 Participants
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Change From Baseline of PR Interval by Timepoint
30min
|
-0.4 msec
Standard Deviation 3.72
|
0 msec
Standard Deviation 6.14
|
-1 msec
Standard Deviation 6.29
|
|
Change From Baseline of PR Interval by Timepoint
60min
|
-2.1 msec
Standard Deviation 3.74
|
-0.3 msec
Standard Deviation 6.79
|
-1.4 msec
Standard Deviation 5.93
|
|
Change From Baseline of PR Interval by Timepoint
75min
|
-2.2 msec
Standard Deviation 4.43
|
-1.8 msec
Standard Deviation 5.53
|
-2.5 msec
Standard Deviation 4.68
|
|
Change From Baseline of PR Interval by Timepoint
90min
|
-2.3 msec
Standard Deviation 4.29
|
-2.4 msec
Standard Deviation 6.81
|
-2.8 msec
Standard Deviation 4.91
|
|
Change From Baseline of PR Interval by Timepoint
105min
|
-1.1 msec
Standard Deviation 4.17
|
-2.2 msec
Standard Deviation 7.91
|
-3.1 msec
Standard Deviation 5.51
|
|
Change From Baseline of PR Interval by Timepoint
2hr
|
-2.8 msec
Standard Deviation 4.51
|
-3.2 msec
Standard Deviation 7.96
|
-2.3 msec
Standard Deviation 7.2
|
|
Change From Baseline of PR Interval by Timepoint
3hr
|
-4 msec
Standard Deviation 6.05
|
-5.1 msec
Standard Deviation 7.34
|
-1.7 msec
Standard Deviation 6.46
|
|
Change From Baseline of PR Interval by Timepoint
4hr
|
-4.6 msec
Standard Deviation 5.81
|
-6.4 msec
Standard Deviation 7.6
|
-3.4 msec
Standard Deviation 5.99
|
|
Change From Baseline of PR Interval by Timepoint
6hr
|
-4.2 msec
Standard Deviation 5.99
|
-5.9 msec
Standard Deviation 8.36
|
-5.3 msec
Standard Deviation 8.64
|
|
Change From Baseline of PR Interval by Timepoint
8hr
|
-7.3 msec
Standard Deviation 6.01
|
-7.8 msec
Standard Deviation 8.58
|
-7.9 msec
Standard Deviation 7.49
|
|
Change From Baseline of PR Interval by Timepoint
12h
|
-2.4 msec
Standard Deviation 7.96
|
-5.5 msec
Standard Deviation 10.72
|
-3.5 msec
Standard Deviation 9.46
|
|
Change From Baseline of PR Interval by Timepoint
24hr
|
1.4 msec
Standard Deviation 6.87
|
-1 msec
Standard Deviation 7.73
|
-0.6 msec
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 Participants
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Change From Baseline of QRS Interval by Timepoint
3hr
|
0.2 msec
Standard Deviation 4.57
|
-0.4 msec
Standard Deviation 4.47
|
0.1 msec
Standard Deviation 5.56
|
|
Change From Baseline of QRS Interval by Timepoint
4hr
|
0.7 msec
Standard Deviation 5.47
|
-0.6 msec
Standard Deviation 6.06
|
1.4 msec
Standard Deviation 5.56
|
|
Change From Baseline of QRS Interval by Timepoint
6hr
|
-7.3 msec
Standard Deviation 7.31
|
-5.8 msec
Standard Deviation 7.42
|
-4.8 msec
Standard Deviation 6.48
|
|
Change From Baseline of QRS Interval by Timepoint
8hr
|
-6.4 msec
Standard Deviation 7.39
|
-6.4 msec
Standard Deviation 6.63
|
-5.5 msec
Standard Deviation 7.9
|
|
Change From Baseline of QRS Interval by Timepoint
12hr
|
-6.4 msec
Standard Deviation 6.26
|
-7 msec
Standard Deviation 7.86
|
-4.2 msec
Standard Deviation 7.99
|
|
Change From Baseline of QRS Interval by Timepoint
24hr
|
-6 msec
Standard Deviation 4.15
|
-8 msec
Standard Deviation 5.13
|
-5.6 msec
Standard Deviation 5.06
|
|
Change From Baseline of QRS Interval by Timepoint
30min
|
3.4 msec
Standard Deviation 5.03
|
3.4 msec
Standard Deviation 3.53
|
3.4 msec
Standard Deviation 3.65
|
|
Change From Baseline of QRS Interval by Timepoint
60min
|
4.7 msec
Standard Deviation 3.54
|
5 msec
Standard Deviation 5.23
|
4.1 msec
Standard Deviation 3.95
|
|
Change From Baseline of QRS Interval by Timepoint
75min
|
4.1 msec
Standard Deviation 5.02
|
4.1 msec
Standard Deviation 3.86
|
3.6 msec
Standard Deviation 3.98
|
|
Change From Baseline of QRS Interval by Timepoint
90min
|
3.5 msec
Standard Deviation 3.61
|
3.5 msec
Standard Deviation 4.4
|
3.2 msec
Standard Deviation 4.13
|
|
Change From Baseline of QRS Interval by Timepoint
105min
|
3.2 msec
Standard Deviation 3.94
|
3.2 msec
Standard Deviation 3.64
|
2.9 msec
Standard Deviation 4.45
|
|
Change From Baseline of QRS Interval by Timepoint
2hr
|
1.4 msec
Standard Deviation 3.35
|
2.1 msec
Standard Deviation 4.62
|
1.9 msec
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 Participants
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Change From Baseline of QTcF by Timepoint
30min
|
0.7 msec
Standard Deviation 1.91
|
-1.8 msec
Standard Deviation 5.06
|
0.2 msec
Standard Deviation 1.94
|
|
Change From Baseline of QTcF by Timepoint
60min
|
0.2 msec
Standard Deviation 1.87
|
-0.7 msec
Standard Deviation 3.62
|
-0.1 msec
Standard Deviation 1.95
|
|
Change From Baseline of QTcF by Timepoint
75min
|
-0.6 msec
Standard Deviation 1.83
|
-1.1 msec
Standard Deviation 3.59
|
-0.7 msec
Standard Deviation 2.92
|
|
Change From Baseline of QTcF by Timepoint
90min
|
0.1 msec
Standard Deviation 2.53
|
-1.3 msec
Standard Deviation 4.15
|
-0.9 msec
Standard Deviation 3.24
|
|
Change From Baseline of QTcF by Timepoint
105min
|
-0.3 msec
Standard Deviation 2.7
|
-1.3 msec
Standard Deviation 3.41
|
-0.8 msec
Standard Deviation 2.53
|
|
Change From Baseline of QTcF by Timepoint
2hr
|
-0.4 msec
Standard Deviation 3.28
|
-2.1 msec
Standard Deviation 6.03
|
-1.5 msec
Standard Deviation 3.31
|
|
Change From Baseline of QTcF by Timepoint
3hr
|
0.3 msec
Standard Deviation 3.27
|
-2 msec
Standard Deviation 5.31
|
-0.4 msec
Standard Deviation 2.42
|
|
Change From Baseline of QTcF by Timepoint
4hr
|
0.4 msec
Standard Deviation 3.08
|
-2 msec
Standard Deviation 5.46
|
-1 msec
Standard Deviation 2.38
|
|
Change From Baseline of QTcF by Timepoint
6hr
|
1.5 msec
Standard Deviation 3.17
|
3.5 msec
Standard Deviation 6.97
|
2.1 msec
Standard Deviation 4.05
|
|
Change From Baseline of QTcF by Timepoint
8hr
|
0.6 msec
Standard Deviation 3.39
|
0.3 msec
Standard Deviation 5.16
|
0.9 msec
Standard Deviation 5.32
|
|
Change From Baseline of QTcF by Timepoint
12hr
|
0.5 msec
Standard Deviation 3.99
|
0.4 msec
Standard Deviation 4.14
|
0.9 msec
Standard Deviation 3.33
|
|
Change From Baseline of QTcF by Timepoint
24hr
|
0 msec
Standard Deviation 3.82
|
-0.7 msec
Standard Deviation 5.56
|
-0.2 msec
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, and 300mg of MCI-186 were included in the analysis. One participant on 300mg was not included due to meeting the exclusion criteria (Protocol Violation).
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Plasma Concentration of MCI-186
30min
|
1039 ng/mL
Standard Deviation 140.0
|
7393 ng/mL
Standard Deviation 1770
|
—
|
|
Plasma Concentration of MCI-186
60min
|
791.3 ng/mL
Standard Deviation 147.0
|
7412 ng/mL
Standard Deviation 1968
|
—
|
|
Plasma Concentration of MCI-186
75min
|
454.4 ng/mL
Standard Deviation 101.6
|
4864 ng/mL
Standard Deviation 1606
|
—
|
|
Plasma Concentration of MCI-186
90min
|
308.3 ng/mL
Standard Deviation 71.22
|
3522 ng/mL
Standard Deviation 1235
|
—
|
|
Plasma Concentration of MCI-186
105min
|
227.6 ng/mL
Standard Deviation 54.48
|
2578 ng/mL
Standard Deviation 932.7
|
—
|
|
Plasma Concentration of MCI-186
2hr
|
176.1 ng/mL
Standard Deviation 43.85
|
1990 ng/mL
Standard Deviation 733.5
|
—
|
|
Plasma Concentration of MCI-186
3hr
|
83.60 ng/mL
Standard Deviation 23.66
|
874.5 ng/mL
Standard Deviation 326.8
|
—
|
|
Plasma Concentration of MCI-186
4hr
|
51.28 ng/mL
Standard Deviation 15.49
|
512.7 ng/mL
Standard Deviation 197.6
|
—
|
|
Plasma Concentration of MCI-186
6hr
|
20.39 ng/mL
Standard Deviation 7.148
|
166.3 ng/mL
Standard Deviation 69.70
|
—
|
|
Plasma Concentration of MCI-186
8hr
|
12.34 ng/mL
Standard Deviation 4.689
|
89.91 ng/mL
Standard Deviation 39.59
|
—
|
|
Plasma Concentration of MCI-186
12hr
|
6.522 ng/mL
Standard Deviation 2.652
|
37.48 ng/mL
Standard Deviation 16.83
|
—
|
|
Plasma Concentration of MCI-186
24hr
|
2.684 ng/mL
Standard Deviation 1.547
|
10.65 ng/mL
Standard Deviation 4.026
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, and 300mg of MCI-186 were included in the analysis. One participant on 300mg was not included due to meeting the exclusion criteria (Protocol Violation).
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Pharmacokinetic(PK) Parameters - Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC 0-inf) of MCI-186
|
1549.22 ng·h/mL
Geometric Coefficient of Variation 20.5
|
12916.94 ng·h/mL
Geometric Coefficient of Variation 33.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to 24h post-dosePopulation: All participants who received 600mg, and 300mg of MCI-186 were included in the analysis. One participant on 300mg was not included due to meeting the exclusion criteria (Protocol Violation).
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
PK Parameters - Maximum Plasma Concentration (Cmax) of MCI-186
|
1030 ng/mL
Geometric Coefficient of Variation 14.1
|
7566 ng/mL
Geometric Coefficient of Variation 25.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 9Population: All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
Outcome measures
| Measure |
MCI-186 60mg
n=27 Participants
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 Participants
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 Participants
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
MCI-186 60mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MCI-186 300mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MCI-186 60mg
n=27 participants at risk
A single dose of 60 mg MCI-186 over 60 min was intravenously administered.
|
MCI-186 300mg
n=26 participants at risk
A single dose of 300 mg MCI-186 over 60 min was intravenously administered.
|
Placebo
n=25 participants at risk
A single dose of 0.9% w/v saline over 60 min was intravenously administered.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/27 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
0.00%
0/26 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
4.0%
1/25 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
3.8%
1/26 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
0.00%
0/25 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
|
Infections and infestations
Pharyngitis
|
3.7%
1/27 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
0.00%
0/26 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
0.00%
0/25 • up to 9 days
All participants who received 600mg, 300mg, and placebo of MCI-186 were included in the analysis. One participant on 300mg , and one patient on placebo were not included due to meeting the exclusion criteria (Protocol Violation). One patient on placebo was not included due to withdrawal of the consent.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: +81-3-5960-9608
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER