Trial Outcomes & Findings for Drug-Drug Interaction Study: ASP2151 and Montelukast (NCT NCT02321748)
NCT ID: NCT02321748
Last Updated: 2019-02-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention
Results posted on
2019-02-27
Participant Flow
Participants took part in the study at one investigative site in United Kingdom from 03-December 2014 to 01-April 2015
Participant milestones
| Measure |
Montelukast, Then Montelukast + ASP2151
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
Montelukast + ASP2151, Then Montelukast
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
First Intervention (4 Days)
|
12
|
12
|
|
Overall Study
Wasout (2weeks)
|
12
|
12
|
|
Overall Study
Second Intervention (4 Days)
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Drug Interaction Study: ASP2151 and Montelukast
Baseline characteristics by cohort
| Measure |
Montelukast, Then Montelukast + ASP2151
n=12 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
Montelukast + ASP2151, Then Montelukast
n=12 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
28.5 year
STANDARD_DEVIATION 7.7 • n=99 Participants
|
33.2 year
STANDARD_DEVIATION 5.8 • n=107 Participants
|
30.8 year
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of Montelukast
|
415.6 ng/mL
Geometric Coefficient of Variation 24.9
|
505.9 ng/mL
Geometric Coefficient of Variation 25.7
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Time of Peak Concentration (Tmax) of Montelukast
|
3 h
Interval 2.0 to 6.0
|
3 h
Interval 1.5 to 5.0
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Area Under the Curve (AUC) of Montelukast
|
2799.2 h*ng/mL
Geometric Coefficient of Variation 29.7
|
3418.5 h*ng/mL
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Half-Life (t1/2) of Montelukast
|
4.87 h
Geometric Coefficient of Variation 27.8
|
5.37 h
Geometric Coefficient of Variation 18.5
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Apparent Volume of Distribution (Vd/f) of Montelukast
|
26.72 L
Standard Deviation 10.482
|
23.76 L
Standard Deviation 7.854
|
PRIMARY outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Apparent Total Body Clearance (CL/f) of Montelukast
|
3.72 L/h
Standard Deviation 1.079
|
3.04 L/h
Standard Deviation 0.857
|
SECONDARY outcome
Timeframe: Up to 32 days after the last doseRefer to the result of adverse event.
Outcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
Non-serious adverse event
|
7 participants
|
2 participants
|
|
Number of Participants With Serious and Non-Serious Adverse Events
serious adverse event
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of Methyl Hydroxymontelukast
|
19.18 ng/mL
Geometric Coefficient of Variation 40.5
|
23.28 ng/mL
Geometric Coefficient of Variation 51.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Time of Peak Concentration (Tmax) of Methyl Hydroxymontelukast
|
4.51 h
Interval 3.0 to 6.0
|
5 h
Interval 2.5 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Area Under the Curve (AUC) of Methyl Hydroxymontelukast
|
150.19 h*ng/mL
Geometric Coefficient of Variation 46.6
|
188.62 h*ng/mL
Geometric Coefficient of Variation 59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
n=24 Participants
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Half-Life (t1/2) of Methyl Hydroxymontelukast
|
4.87 h
Geometric Coefficient of Variation 24.7
|
4.83 h
Geometric Coefficient of Variation 25.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of ASP2151
|
1679.7 ng/mL
Geometric Coefficient of Variation 32.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Time of Peak Concentration (Tmax) of ASP2151
|
3 h
Interval 1.5 to 4.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Area Under the Curve (AUC) of ASP2151
|
20928.2 h*ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Half-Life (t1/2) of ASP2151
|
8.406 h
Geometric Coefficient of Variation 17.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Apparent Volume of Distribution (Vd/f) of ASP2151
|
246.9 L
Standard Deviation 104.44
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second interventionOutcome measures
| Measure |
Montelukast
n=24 Participants
10mg montelukast alone followed by 10mg montelukast + 400mg ASP2151
Montelukast
ASP2151
|
ASP2151
10mg montelukast + 400mg ASP2151 followed by 10mg montelukast alone
Montelukast
ASP2151
|
|---|---|---|
|
Apparent Total Body Clearance (CL/f) of ASP2151
|
19.95 L/h
Standard Deviation 6.525
|
—
|
Adverse Events
Montelukast
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ASP2151
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 |
Montelukast
n=24 participants at risk
Participants received montelukast 10 mg alone in first or second intervention
|
ASP2151
n=24 participants at risk
Participants received montelukast 10 mg with ASP2151 400mg in first or second intervention
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
2/24 • Up to 32 days after the last dose
|
0.00%
0/24 • Up to 32 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Up to 32 days after the last dose
|
0.00%
0/24 • Up to 32 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • Up to 32 days after the last dose
|
4.2%
1/24 • Up to 32 days after the last dose
|
|
Infections and infestations
Gingivitis
|
4.2%
1/24 • Up to 32 days after the last dose
|
0.00%
0/24 • Up to 32 days after the last dose
|
|
Infections and infestations
Nasopharynｇitis
|
0.00%
0/24 • Up to 32 days after the last dose
|
4.2%
1/24 • Up to 32 days after the last dose
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • Up to 32 days after the last dose
|
0.00%
0/24 • Up to 32 days after the last dose
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Up to 32 days after the last dose
|
0.00%
0/24 • 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