Trial Outcomes & Findings for A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003) (NCT NCT01343407)
NCT ID: NCT01343407
Last Updated: 2019-03-01
Results Overview
The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)
Results posted on
2019-03-01
Participant Flow
This was a 2-part study. Part 1 was a procedural pilot, performed first and including placebo run-in (Period 1), with no study drug administration. Part 2 began with pre-randomization placebo run-in (Period 1), followed by 3 randomized, crossover treatment periods (Periods 2, 3, and 4). The Participant Flow applies only to randomized participants.
Participant milestones
| Measure |
Sequence 1
Placebo→MK-1029 60 mg→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
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Sequence 2
MK-1029 60 mg→MK-1029 500 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
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Sequence 3
MK-1029 500 mg→Placebo→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 4
Placebo→MK-1029 500 mg→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 5
MK-1029 500 mg→MK-1029 60 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 6
MK-1029 60 mg→Placebo→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
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|---|---|---|---|---|---|---|
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First Treatment Period (Part 2)
STARTED
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2
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2
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3
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3
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3
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3
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First Treatment Period (Part 2)
COMPLETED
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2
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2
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3
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3
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3
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3
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First Treatment Period (Part 2)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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First Washout (Part 2)
STARTED
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2
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2
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3
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3
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3
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3
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First Washout (Part 2)
COMPLETED
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2
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2
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3
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3
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3
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3
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First Washout (Part 2)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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Second Treatment Period (Part 2)
STARTED
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2
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2
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3
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3
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3
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3
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Second Treatment Period (Part 2)
COMPLETED
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2
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2
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2
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3
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3
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3
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Second Treatment Period (Part 2)
NOT COMPLETED
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0
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0
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1
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0
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0
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0
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Second Washout (Part 2)
STARTED
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2
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2
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2
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3
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3
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3
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Second Washout (Part 2)
COMPLETED
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2
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2
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1
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3
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3
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3
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Second Washout (Part 2)
NOT COMPLETED
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0
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0
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1
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0
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0
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0
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Third Treatment Period (Part 2)
STARTED
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2
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2
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1
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3
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3
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3
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Third Treatment Period (Part 2)
COMPLETED
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2
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2
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1
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3
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3
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3
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Third Treatment Period (Part 2)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Sequence 1
Placebo→MK-1029 60 mg→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 2
MK-1029 60 mg→MK-1029 500 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 3
MK-1029 500 mg→Placebo→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 4
Placebo→MK-1029 500 mg→ MK-1029 60 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 5
MK-1029 500 mg→MK-1029 60 mg→Placebo. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
Sequence 6
MK-1029 60 mg→Placebo→ MK-1029 500 mg. Participants received 5 days of crossover treatment (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods.
|
|---|---|---|---|---|---|---|
|
Second Treatment Period (Part 2)
Adverse Event
|
0
|
0
|
1
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0
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0
|
0
|
|
Second Washout (Part 2)
Withdrawal by Subject
|
0
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0
|
1
|
0
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0
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0
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Baseline Characteristics
A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)
Baseline characteristics by cohort
| Measure |
Randomized Participants
n=16 Participants
Crossover treatment with MK-1029 60 mg, MK-1029 500 mg, and matching placebo
|
|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)Population: Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.
The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
Outcome measures
| Measure |
MK-1029 60 mg
n=11 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=12 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=9 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
|
-10.6 Percent change
Interval -22.5 to 1.3
|
-7.3 Percent change
Interval -18.3 to 3.6
|
11.6 Percent change
Interval -1.0 to 24.3
|
PRIMARY outcome
Timeframe: From 3 to 8 hours after allergen challenge on Day 5 of each treatment periodPopulation: Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.
The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L\*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.
Outcome measures
| Measure |
MK-1029 60 mg
n=14 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=16 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=15 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
|
41.24 L*hr
Interval 18.16 to 93.66
|
49.76 L*hr
Interval 31.02 to 79.83
|
86.37 L*hr
Interval 55.79 to 133.7
|
PRIMARY outcome
Timeframe: Up to 26 days in each treatment periodPopulation: All randomized participants who received at least one dose of study treatment and had follow-up.
The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-1029 60 mg
n=14 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=16 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=16 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
11 Participants
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days in each treatment periodPopulation: All randomized participants who received at least one dose of study treatment.
The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-1029 60 mg
n=14 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=16 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=16 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Number of Participants Discontinuing Treatment Due to an AE
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment periodPopulation: Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.
The concentration of CD11b in whole blood samples was assessed. The percent-inhibition of CD11b (a cell-surface biomarker on activated eosinophils) was assessed following inhaled allergen challenge on Day 5. Inhibition of CD11b expression was assessed by analyzing the % inhibition of CD11b expression from baseline (Day -1) using a linear mixed-effects model with period, treatment, time, and treatment by time as fixed terms and subject as a random term. Outcome Measure 7 shows CD11b expression values at baseline.
Outcome measures
| Measure |
MK-1029 60 mg
n=13 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=16 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=15 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
|
89.9 Percentage of inhibition
Interval 71.8 to 108.0
|
87.4 Percentage of inhibition
Interval 71.2 to 103.5
|
4.1 Percentage of inhibition
Interval -12.6 to 20.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -1), pre-antigen challengePopulation: Participants who were compliant with the protocol sufficiently to ensure their data would be likely to exhibit the effects of treatment were included.
Baseline values of the percent (%) sputum eosinophils were measured pre-antigen challenge on Day -1. The baseline % eosinophil values were provided to assess the change from baseline after treatment.
Outcome measures
| Measure |
MK-1029 60 mg
n=13 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=13 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=12 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Baseline (Pre-Treatment) Percent (%) Eosinophils
|
18.42 % sputum eosinophils
Interval 0.47 to 80.56
|
17.04 % sputum eosinophils
Interval 0.66 to 78.22
|
11.99 % sputum eosinophils
Interval 0.48 to 23.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, predosePopulation: Participants who were compliant with the protocol sufficiently to ensure their data would be likely to exhibit the effects of treatment were included.
Baseline values for the antibody-specific expression of CD11b in whole blood samples, as obtained by flow cytometry, were obtained. The baseline CD11b values were obtained before treatment with MK-1029 60 mg, MK-1029 500 mg, or placebo, and were used to assess the effects of treatment.
Outcome measures
| Measure |
MK-1029 60 mg
n=13 Participants
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
MK-1029 500 mg
n=16 Participants
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=15 Participants
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Baseline Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
|
62619 Antibody fluorescence units
Standard Deviation 28790
|
62254 Antibody fluorescence units
Standard Deviation 13690
|
63398 Antibody fluorescence units
Standard Deviation 22022
|
Adverse Events
60 mg MK-1029
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
500 mg MK-1029
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
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 |
60 mg MK-1029
n=14 participants at risk
Participants received 5 days of treatment with MK-1029 60 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
500 mg MK-1029
n=16 participants at risk
Participants received 5 days of treatment with MK-1029 500 mg (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
Placebo
n=16 participants at risk
Participants received 5 days of treatment with placebo (once-daily dosing) in 3 periods, followed by a minimum 21-day washout between treatment periods
|
|---|---|---|---|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
General disorders
Catheter site erythema
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
General disorders
Catheter site pain
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
General disorders
Chest discomfort
|
21.4%
3/14 • Number of events 3 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
18.8%
3/16 • Number of events 6 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 3 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
37.5%
6/16 • Number of events 7 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
31.2%
5/16 • Number of events 7 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
21.4%
3/14 • Number of events 3 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
25.0%
4/16 • Number of events 4 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
37.5%
6/16 • Number of events 10 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
12.5%
2/16 • Number of events 2 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
2/14 • Number of events 2 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
7.1%
1/14 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
6.2%
1/16 • Number of events 1 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
0.00%
0/16 • Up to 26 days in each treatment period
One participant had an episode of respiratory distress (a serious AE) during the placebo run-in, and was not randomized to study treatment. The at-risk population for AEs is all participants who received study drug in a treatment period.
|
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 This study is intended for publication, even if terminated prematurely. 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. SPONSOR review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER