Trial Outcomes & Findings for Drug-Drug Interaction Study: ASP2151 and Midazolam (NCT NCT02403635)
NCT ID: NCT02403635
Last Updated: 2019-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26
Results posted on
2019-02-21
Participant Flow
Participants took part in the study at one investigative site in United Kingdom from 18-March 2015 to 28-May 2015
Participant milestones
| Measure |
Midazolam + ASP2151
400 mg ASP2151 followed by 7.5 mg midazolam
Midazolam
ASP2151
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
Screening (28 Days)
|
27
|
|
Overall Study
Received the First Dose
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Midazolam + ASP2151
400 mg ASP2151 followed by 7.5 mg midazolam
Midazolam
ASP2151
|
|---|---|
|
Overall Study
Not eligible
|
9
|
Baseline Characteristics
Drug-Drug Interaction Study: ASP2151 and Midazolam
Baseline characteristics by cohort
| Measure |
Midazolam + ASP2151
n=18 Participants
400 mg ASP2151 followed by 7.5 mg midazolam
Midazolam
ASP2151
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
30.7 year
STANDARD_DEVIATION 7.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Midazolam
|
34.5 ng/mL
Geometric Coefficient of Variation 21.2
|
23.4 ng/mL
Geometric Coefficient of Variation 32.5
|
38.8 ng/mL
Geometric Coefficient of Variation 23.1
|
36.8 ng/mL
Geometric Coefficient of Variation 41.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of Midazolam
|
0.5 h
Interval 0.5 to 1.52
|
0.5 h
Interval 0.25 to 150.0
|
0.5 h
Interval 0.5 to 1.5
|
0.5 h
Interval 0.28 to 2.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of Midazolam
|
113.1 h*ng/mL
Geometric Coefficient of Variation 28.1
|
58 h*ng/mL
Geometric Coefficient of Variation 29.2
|
124.4 h*ng/mL
Geometric Coefficient of Variation 31.7
|
122.1 h*ng/mL
Geometric Coefficient of Variation 37.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of Midazolam
|
4.2 h
Geometric Coefficient of Variation 37
|
3.3 h
Geometric Coefficient of Variation 52.7
|
4.3 h
Geometric Coefficient of Variation 43.7
|
4.1 h
Geometric Coefficient of Variation 52.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 32 days after the last doseRefer to the result of adverse event.
Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
Non-serious adverse event
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious and Non-Serious Adverse Events
serious adverse event
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of 1-hydroxymidazolam
|
15.7 ng/mL
Geometric Coefficient of Variation 33.2
|
15.9 ng/mL
Geometric Coefficient of Variation 40.9
|
14.9 ng/mL
Geometric Coefficient of Variation 35
|
14.2 ng/mL
Geometric Coefficient of Variation 59.3
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of 1-hydroxymidazolam
|
0.5 h
Interval 0.5 to 1.52
|
0.5 h
Interval 0.25 to 150.0
|
0.5 h
Interval 0.5 to 1.5
|
0.5 h
Interval 0.28 to 1.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of 1-hydroxymidazolam
|
44 h*ng/mL
Geometric Coefficient of Variation 30.3
|
39 h*ng/mL
Geometric Coefficient of Variation 32.3
|
42.2 h*ng/mL
Geometric Coefficient of Variation 31.3
|
40.4 h*ng/mL
Geometric Coefficient of Variation 36.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of 1-hydroxymidazolam
|
3.8 h
Geometric Coefficient of Variation 39.7
|
3.1 h
Geometric Coefficient of Variation 47.4
|
3.5 h
Geometric Coefficient of Variation 35.4
|
3.3 h
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 5 to 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
n=18 Participants
Day 9 pre-dose
|
Day 10
n=18 Participants
Day 10 pre-dose
|
Day 11
n=18 Participants
Day 11 pre-dose
|
Day 12
n=18 Participants
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of ASP2151
|
277.6 ng/mL
Standard Deviation 73.47
|
265.7 ng/mL
Standard Deviation 64.57
|
238.9 ng/mL
Standard Deviation 65.6
|
240.7 ng/mL
Standard Deviation 67.73
|
223.9 ng/mL
Standard Deviation 63.68
|
228.5 ng/mL
Standard Deviation 67.44
|
209.7 ng/mL
Standard Deviation 66.47
|
214.2 ng/mL
Standard Deviation 50.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ASP2151
|
1761.4 ng/mL
Geometric Coefficient of Variation 37.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of ASP2151
|
3 h
Interval 1.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Area Under Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of ASP2151
|
17167 h*ng/mL
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151
|
19334.2 h*ng/mL
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of ASP2151
|
7.3 h
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of ASP2151
|
225.9 L
Standard Deviation 65.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12Outcome measures
| Measure |
Day 1
n=24 Participants
7.5 mg midazolam alone
|
Day 12
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
7.5 mg midazolam alone
|
Day 26
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of ASP2151
|
21.61 L/h
Standard Deviation 6.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Midazolam
|
111 h*ng/mL
Geometric Coefficient of Variation 28
|
56.7 h*ng/mL
Geometric Coefficient of Variation 28.8
|
121.9 h*ng/mL
Geometric Coefficient of Variation 30.7
|
118.9 h*ng/mL
Geometric Coefficient of Variation 36.2
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of Midazolam
|
406.5 L
Standard Deviation 46.3
|
622 L
Standard Deviation 47
|
370.8 L
Standard Deviation 43.1
|
366.6 L
Standard Deviation 41
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26Outcome measures
| Measure |
Day 1
n=18 Participants
7.5 mg midazolam alone
|
Day 12
n=18 Participants
7.5 mg midazolam with 400 mg ASP2151
|
Day 19
n=18 Participants
7.5 mg midazolam alone
|
Day 26
n=18 Participants
7.5 mg midazolam alone
|
Day 9
Day 9 pre-dose
|
Day 10
Day 10 pre-dose
|
Day 11
Day 11 pre-dose
|
Day 12
Day 12 pre-dose
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Midazolam
|
444 L/h
Standard Deviation 187.33
|
679.1 L/h
Standard Deviation 276.5
|
401.3 L/h
Standard Deviation 163.74
|
394 L/h
Standard Deviation 153.76
|
—
|
—
|
—
|
—
|
Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
ASP2151 After Midazolam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Midazolam With ASP2151
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midazolam
n=18 participants at risk
7.5 mg midazolam
|
ASP2151 After Midazolam
n=18 participants at risk
400 mg ASP2151 after 7.5 mg midazolam
|
Midazolam With ASP2151
n=18 participants at risk
7.5 mg midazolam with 400 mg ASP2151
|
Total
n=18 participants at risk
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
94.4%
17/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
94.4%
17/18 • Up to 32 days after the last dose
|
100.0%
18/18 • Up to 32 days after the last dose
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
11.1%
2/18 • Up to 32 days after the last dose
|
16.7%
3/18 • Up to 32 days after the last dose
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
11.1%
2/18 • Up to 32 days after the last dose
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
16.7%
3/18 • Up to 32 days after the last dose
|
22.2%
4/18 • Up to 32 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
11.1%
2/18 • Up to 32 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
General disorders
Catheter site inflammation
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
General disorders
Energy increased
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • Up to 32 days after the last dose
|
0.00%
0/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
5.6%
1/18 • Up to 32 days after the last dose
|
Additional Information
Maruho Co.,Ltd. Kyoto R&D Center
Clinical Development Dept.
Phone: +81-75-325-3255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place