Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED) (NCT NCT00636207)
NCT ID: NCT00636207
Last Updated: 2024-05-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Up to 14 days after last dose of study drug
Results posted on
2024-05-09
Participant Flow
Participants were recruited from 3 study sites located in the United States.
Participant milestones
| Measure |
Part III - Placebo
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
Part I - Montelukast
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
|
Part I - Montelukast and Placebo
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
|
Part II - Montelukast
Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
|
Part II - Placebo
Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
|
Part III - Montelukast
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
Part III - Montelukast and Placebo
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
8
|
18
|
6
|
9
|
1
|
|
Overall Study
COMPLETED
|
3
|
0
|
7
|
18
|
6
|
8
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part III - Placebo
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
Part I - Montelukast
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
|
Part I - Montelukast and Placebo
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
|
Part II - Montelukast
Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
|
Part II - Placebo
Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
|
Part III - Montelukast
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
Part III - Montelukast and Placebo
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Part I
n=9 Participants
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
|
Part II
n=24 Participants
Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
|
Part III
n=13 Participants
Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 10.45 • n=99 Participants
|
31.0 years
STANDARD_DEVIATION 12.68 • n=107 Participants
|
36.3 years
STANDARD_DEVIATION 10.32 • n=206 Participants
|
33.8 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after last dose of study drugPopulation: Safety Population: All participants who received at least one dose of study drug
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=12 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=18 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=19 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=18 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event
|
2 participants
|
4 participants
|
6 participants
|
9 participants
|
5 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Up to 7 days after last dose of study drugPopulation: Safety Population: All participants who received at least one dose of study drug
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=12 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=18 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=19 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=18 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=5 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=6 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=6 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=6 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
|
NA ng/mL*hr
Standard Deviation NA
Plasma level below lower limit of quantitation
|
NA ng/mL*hr
Standard Deviation NA
Plasma level below lower limit of quantitation
|
NA ng/mL*hr
Standard Deviation NA
Plasma level below lower limit of quantitation
|
155 ng/mL*hr
Standard Deviation 18.5
|
491 ng/mL*hr
Standard Deviation 71
|
1600 ng/mL*hr
Standard Deviation 260
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
AUC 0-24hr of Montelukast - Multiple Doses
Part II Day 1 (n=6)
|
132 ng/mL*hr
Standard Deviation 43.7
|
403 ng/mL*hr
Standard Deviation 115
|
1576 ng/mL*hr
Standard Deviation 380
|
—
|
—
|
—
|
|
AUC 0-24hr of Montelukast - Multiple Doses
Part II Day 5 (n=6)
|
214 ng/mL*hr
Standard Deviation 76.3
|
576 ng/mL*hr
Standard Deviation 148
|
1850 ng/mL*hr
Standard Deviation 304
|
—
|
—
|
—
|
|
AUC 0-24hr of Montelukast - Multiple Doses
Part III Day 1 (n=6)
|
NA ng/mL*hr
Standard Deviation NA
Not obtained in Part III
|
357 ng/mL*hr
Standard Deviation 109
|
1500 ng/mL*hr
Standard Deviation 521
|
—
|
—
|
—
|
|
AUC 0-24hr of Montelukast - Multiple Doses
Part III Day 10 (n=6)
|
NA ng/mL*hr
Standard Deviation NA
Not obtained in Part III
|
526 ng/mL*hr
Standard Deviation 133
|
1880 ng/mL*hr
Standard Deviation 530
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=5 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=6 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=6 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=6 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
|
NA ng/mL
Standard Deviation NA
Plasma level below lower limit of quantitation
|
5.10 ng/mL
Standard Deviation 0.977
|
5.24 ng/mL
Standard Deviation 0.914
|
18.5 ng/mL
Standard Deviation 4.15
|
54.3 ng/mL
Standard Deviation 12.7
|
224 ng/mL
Standard Deviation 47.3
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Cmax of Montelukast - Multiple Doses
Part II Day 1 (n=6)
|
13.8 ng/mL
Standard Deviation 4.96
|
60 ng/mL
Standard Deviation 13.1
|
233 ng/mL
Standard Deviation 30.2
|
—
|
—
|
—
|
|
Cmax of Montelukast - Multiple Doses
Part II Day 5 (n=6)
|
23.4 ng/mL
Standard Deviation 6.5
|
76 ng/mL
Standard Deviation 15.3
|
242 ng/mL
Standard Deviation 38
|
—
|
—
|
—
|
|
Cmax of Montelukast - Multiple Doses
Part III Day 1 (n=6)
|
NA ng/mL
Standard Deviation NA
Not obtained in Part III
|
44.3 ng/mL
Standard Deviation 16.6
|
184 ng/mL
Standard Deviation 66.6
|
—
|
—
|
—
|
|
Cmax of Montelukast - Multiple Doses
Part III Day 10 (n=6)
|
NA ng/mL
Standard Deviation NA
Not obtained in Part III
|
64.8 ng/mL
Standard Deviation 13.0
|
225 ng/mL
Standard Deviation 84.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=5 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=6 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=6 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=6 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Montelukast - Single Dose
|
NA hours
Plasma level below lower limit of quantitation
|
2.5 hours
Interval 0.8 to 4.0
|
4.0 hours
Interval 0.5 to 4.0
|
2.4 hours
Interval 0.5 to 7.0
|
0.8 hours
Interval 0.5 to 4.0
|
0.5 hours
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Tmax of Montelukast - Multiple Doses
Part II Day 1 (n=6)
|
2.4 hours
Interval 0.7 to 7.0
|
0.5 hours
Interval 0.5 to 0.7
|
0.5 hours
Interval 0.5 to 0.7
|
—
|
—
|
—
|
|
Tmax of Montelukast - Multiple Doses
Part II Day 5 (n=6)
|
0.7 hours
Interval 0.5 to 0.7
|
0.5 hours
Interval 0.5 to 0.7
|
0.6 hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
|
Tmax of Montelukast - Multiple Doses
Part III Day 1 (n=6)
|
NA hours
Not obtained in Part III
|
0.5 hours
Interval 0.5 to 4.0
|
0.5 hours
Interval 0.2 to 7.0
|
—
|
—
|
—
|
|
Tmax of Montelukast - Multiple Doses
Part III Day 10 (n=6)
|
NA hours
Not obtained in Part III
|
0.5 hours
Interval 0.2 to 0.7
|
0.5 hours
Interval 0.5 to 0.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=7 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=5 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=6 Participants
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=6 Participants
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=6 Participants
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
|
NA hours
Standard Deviation NA
Plasma level below lower limit of quantitation
|
NA hours
Standard Deviation NA
Plasma level below lower limit of quantitation
|
NA hours
Standard Deviation NA
Plasma level below lower limit of quantitation
|
5.7 hours
Standard Deviation 2.1
|
6.9 hours
Standard Deviation 0.9
|
5.7 hours
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Up to 24 hours postdosePopulation: Per Protocol Population: All participants who complied with the protocol
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
t1/2 of Montelukast - Multiple Doses
Part II Day 5 (n=6)
|
8.2 hours
Standard Deviation 2.5
|
7.6 hours
Standard Deviation 2.5
|
7.7 hours
Standard Deviation 2.4
|
—
|
—
|
—
|
|
t1/2 of Montelukast - Multiple Doses
Part III Day 10 (n=6)
|
NA hours
Standard Deviation NA
Not obtained in Part III
|
8.1 hours
Standard Deviation 1.4
|
7.4 hours
Standard Deviation 1.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 10 days after first dose of study drugPopulation: Per Protocol Population: All participants who complied with the protocol
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
Part II (n=6)
|
1.61 ratio
|
1.44 ratio
|
1.2 ratio
|
—
|
—
|
—
|
|
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
Part III (n=6)
|
NA ratio
Not obtained in Part III
|
1.19 ratio
|
1.26 ratio
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 10 days after first dose of study drugPopulation: Per Protocol Population: All participants who complied with the protocol
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Outcome measures
| Measure |
Montelukast 0.1 mg
n=6 Participants
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=6 Participants
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=6 Participants
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Cmax Accumulation Ratio of Montelukast - Multiple Doses
Part II (n=6)
|
1.73 ratio
|
1.27 ratio
|
1.03 ratio
|
—
|
—
|
—
|
|
Cmax Accumulation Ratio of Montelukast - Multiple Doses
Part III (n=6)
|
NA ratio
Not obtained in Part III
|
1.03 ratio
|
1.22 ratio
|
—
|
—
|
—
|
Adverse Events
Montelukast 0.1 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Montelukast 0.3 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Montelukast 1 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Montelukast 3 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Montelukast 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Montelukast 0.1 mg
n=7 participants at risk
Participants receiving Montelukast 0.1 mg inhalation powder
|
Montelukast 0.3 mg
n=7 participants at risk
Participants receiving Montelukast 0.3 mg inhalation powder
|
Montelukast 1 mg
n=12 participants at risk
Participants receiving Montelukast 1 mg inhalation powder
|
Montelukast 3 mg
n=18 participants at risk
Participants receiving Montelukast 3 mg inhalation powder
|
Montelukast 10 mg
n=19 participants at risk
Participants receiving Montelukast 10 mg inhalation powder
|
Placebo
n=18 participants at risk
Participants receiving Placebo inhalation powder
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
8.3%
1/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
8.3%
1/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
General disorders
Chest Discomfort
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
General disorders
Chest Pain
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
8.3%
1/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Infections and infestations
Laryngitis
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
28.6%
2/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.3%
1/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
10.5%
2/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
11.1%
2/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
41.7%
5/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
16.7%
3/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
16.7%
3/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
10.5%
2/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
16.7%
3/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
11.1%
2/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
8.3%
1/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
14.3%
1/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.3%
1/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.3%
1/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.6%
1/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/7 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/12 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
5.3%
1/19 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
0.00%
0/18 • Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER