Trial Outcomes & Findings for Drug-Drug Interaction Study: ASP2151 and Ciclosporin (NCT NCT02280421)
NCT ID: NCT02280421
Last Updated: 2019-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.
Results posted on
2019-05-03
Participant Flow
Participants took part in the study at one investigative site in United Kingdom from 06-October 2014 to 10-February 2015 Each participant was randomised to 2 groups. One group was received ASP 400mg in first intervention and 1200mg in other group. There was a washout of at least 2 weeks between the interventions.
Participants received a single dose of 400mg or 1200mg ASP2151 on Days 1 and 7, 100 mg ciclosporin twice daily on Days 3-9, and once in the morning of Day 10. Two participants were withdrawn during the washout period, in the second intervention, another participants were replaced.
Participant milestones
| Measure |
ASP2151 400mg
"ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin" first, then "ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin"
|
ASP2151 1200mg
"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin" first, then "ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
|
|---|---|---|
|
First Intervention(2 Weeks)
STARTED
|
12
|
12
|
|
First Intervention(2 Weeks)
Received Intervention
|
12
|
12
|
|
First Intervention(2 Weeks)
COMPLETED
|
12
|
12
|
|
First Intervention(2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
12
|
12
|
|
Washout (2 Weeks)
COMPLETED
|
11
|
11
|
|
Washout (2 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention(2 Weeks)
STARTED
|
12
|
12
|
|
Second Intervention(2 Weeks)
Received Intervention
|
12
|
12
|
|
Second Intervention(2 Weeks)
COMPLETED
|
12
|
12
|
|
Second Intervention(2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
ASP2151 400mg
"ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin" first, then "ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin"
|
ASP2151 1200mg
"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin" first, then "ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
|
|---|---|---|
|
Washout (2 Weeks)
Adverse Event
|
0
|
1
|
|
Washout (2 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Drug-Drug Interaction Study: ASP2151 and Ciclosporin
Baseline characteristics by cohort
| Measure |
ASP2151 400mg
n=13 Participants
"ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin" first, then "ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin"
|
ASP2151 1200mg
n=13 Participants
"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin" first, then "ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.6 year
STANDARD_DEVIATION 7.4 • n=5 Participants
|
31.8 year
STANDARD_DEVIATION 7.1 • n=7 Participants
|
32.7 year
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ASP2151
|
1818.0 ng/mL
Geometric Coefficient of Variation 26.1
|
1202.3 ng/mL
Geometric Coefficient of Variation 31.5
|
3573.1 ng/mL
Geometric Coefficient of Variation 26.1
|
2452.1 ng/mL
Geometric Coefficient of Variation 31.4
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of ASP2151
|
3.00 h
Interval 0.5 to 4.02
|
4.00 h
Interval 1.0 to 8.0
|
3.00 h
Interval 2.0 to 4.0
|
4.00 h
Interval 2.0 to 8.0
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of ASP2151
|
23307.4 h*ng/mL
Geometric Coefficient of Variation 27.1
|
19013.5 h*ng/mL
Geometric Coefficient of Variation 31.4
|
48051.2 h*ng/mL
Geometric Coefficient of Variation 25.0
|
37940.8 h*ng/mL
Geometric Coefficient of Variation 25.9
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Half-Life (t1/2) of ASP2151
|
7.755 h
Geometric Coefficient of Variation 12.1
|
8.593 h
Geometric Coefficient of Variation 16.4
|
7.457 h
Geometric Coefficient of Variation 13.2
|
8.326 h
Geometric Coefficient of Variation 14.1
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma
|
17.745 L/h
Standard Deviation 4.6288
|
21.917 L/h
Standard Deviation 5.9182
|
25.695 L/h
Standard Deviation 6.3004
|
32.699 L/h
Standard Deviation 9.3284
|
PRIMARY outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of ASP2151
|
196.9 L
Standard Deviation 45.72
|
269.6 L
Standard Deviation 69.57
|
276.5 L
Standard Deviation 69.55
|
395.3 L
Standard Deviation 118.47
|
SECONDARY outcome
Timeframe: Up to 31 days after the Day 7 dose of ASP2151Refer to the result of adverse event.
Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
Non-serious adverse event
|
15 participants
|
15 participants
|
—
|
—
|
|
Number of Participants With Serious and Non-Serious Adverse Events
serious adverse event
|
0 participants
|
0 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ASP1955888-00
|
173.0 ng/mL
Geometric Coefficient of Variation 35.2
|
132.6 ng/mL
Geometric Coefficient of Variation 28.1
|
387.3 ng/mL
Geometric Coefficient of Variation 38.1
|
307.2 ng/mL
Geometric Coefficient of Variation 42.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of AS195588-00
|
3.03 h
Interval 1.0 to 6.0
|
4.00 h
Interval 3.0 to 8.08
|
3.53 h
Interval 2.0 to 4.0
|
4.00 h
Interval 3.0 to 6.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of AS195588-00
|
2614.4 h*ng/mL
Geometric Coefficient of Variation 27.4
|
2441.3 h*ng/mL
Geometric Coefficient of Variation 20.2
|
6147.4 h*ng/mL
Geometric Coefficient of Variation 29.7
|
5584.5 h*ng/mL
Geometric Coefficient of Variation 31.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Half-Life (t1/2) of AS195588-00
|
8.59 h
Geometric Coefficient of Variation 15.3
|
9.62 h
Geometric Coefficient of Variation 18.4
|
8.25 h
Geometric Coefficient of Variation 14.3
|
9.02 h
Geometric Coefficient of Variation 16.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of Ciclosporin
|
491.0 ng/mL
Geometric Coefficient of Variation 18.6
|
482.3 ng/mL
Geometric Coefficient of Variation 18.3
|
467.0 ng/mL
Geometric Coefficient of Variation 23.7
|
440.0 ng/mL
Geometric Coefficient of Variation 18.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Time of Peak Concentration (Tmax) of Ciclosporin
|
2.00 h
Interval 1.0 to 3.0
|
2.00 h
Interval 0.92 to 3.0
|
2.00 h
Interval 1.0 to 3.0
|
2.00 h
Interval 0.98 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.Outcome measures
| Measure |
ASP2151 400mg Alone
n=24 Participants
ASP2151(400mg) alone
|
ASP2151 400mg With Ciclosporin
n=24 Participants
ASP2151 400mg + 100mg ciclosporin
ASP2151 400mg + 100mg ciclosporin
|
ASP2151 1200mg Alone
n=24 Participants
ASP2151(1200mg) alone
|
ASP2151 1200mg With Ciclosporin
n=24 Participants
ASP2151 1200mg + 100mg ciclosporin
ASP2151 1200mg + 100mg ciclosporin
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of Ciclosporin
|
1944.3 h*ng/mL
Geometric Coefficient of Variation 19.7
|
2011.0 h*ng/mL
Geometric Coefficient of Variation 22.1
|
1894.2 h*ng/mL
Geometric Coefficient of Variation 22.9
|
1888.2 h*ng/mL
Geometric Coefficient of Variation 19.6
|
Adverse Events
ASP2151(400mg) Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ciclosporin After ASP2151(400mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ciclosporin With ASP2151(400mg)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ASP2151(1200mg) Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ciclosporin After ASP2151(1200mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ciclosporin With ASP2151(1200mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASP2151(400mg) Alone
n=24 participants at risk
Participants who administered ASP2151 alone during the treatment session 1(ASP2151 400mg)
|
Ciclosporin After ASP2151(400mg)
n=24 participants at risk
Participants who administered ciclosporin alone during the treatment session 1(ASP2151 400mg)
|
Ciclosporin With ASP2151(400mg)
n=24 participants at risk
Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 400mg)
|
ASP2151(1200mg) Alone
n=24 participants at risk
Participants who administered ASP2151 alone during the treatment session 1(ASP2151 1200mg)
|
Ciclosporin After ASP2151(1200mg)
n=24 participants at risk
Participants who administered ciclosporin alone during the treatment session 1(ASP2151 1200mg)
|
Ciclosporin With ASP2151(1200mg)
n=24 participants at risk
Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 1200mg)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
16.7%
4/24 • 14 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
8.3%
2/24 • 14 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
8.3%
2/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
12.5%
3/24 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
General disorders
Feeling hot
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
General disorders
Influenza-like illness
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
General disorders
Catheter site pain
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
General disorders
Catheter site related reaction
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
General disorders
Axillary pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
4.2%
1/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
0.00%
0/24 • 14 days
|
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