Trial Outcomes & Findings for Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014) (NCT NCT02476890)
NCT ID: NCT02476890
Last Updated: 2019-06-18
Results Overview
The concentration of capsaicin inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of capsaicin for cough challenge were 0.3 micromoles (µM), 1 µM, 3 µM, 10 µM, 30 µM, 100 µM, 300 µM, and 1000 µM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of capsaicin with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).
COMPLETED
PHASE2
36 participants
Average of 1, 3, and 5 hours post-dose
2019-06-18
Participant Flow
A 6-day Screening period (Day -6 to Day -1) ensured that each participant met all the specified eligibility criteria. In addition, cough reflex sensitivity was measured at Screening by standard clinical methodology using cough challenge in response to four agents (capsaicin, citric acid, adenosine triphosphate (ATP), and distilled water).
Participant milestones
| Measure |
Placebo Then Gefapixant 100 mg/Healthy (Sequence A)
Healthy participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
|
Gefapixant 100 mg Then Placebo/Healthy (Sequence B)
Healthy participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
|
Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)
Chronic Cough participants in Sequence A received a single dose of placebo in treatment Period 1 then a single dose of gefapixant 100 mg in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
|
Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)
Chronic Cough participants in Sequence B received a single dose of gefapixant 100 mg in treatment Period 1 then a single dose of placebo in treatment Period 2. There was a washout period of at least 48 hours between Period 1 and Period 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
12
|
12
|
|
Overall Study
Washout
|
6
|
6
|
12
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014)
Baseline characteristics by cohort
| Measure |
Placebo Then Gefapixant 100 mg/Healthy (Sequence A)
n=6 Participants
Healthy participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
|
Gefapixant 100 mg Then Placebo/Healthy (Sequence B)
n=6 Participants
Healthy participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
|
Placebo Then Gefapixant 100 mg/Chronic Cough (Sequence A)
n=12 Participants
Chronic Cough Participants in Sequence A were randomized to receive placebo in treatment Period 1, then gefapixant 100 mg in treatment Period 2.
|
Gefapixant 100 mg Then Placebo/Chronic Cough (Sequence B)
n=12 Participants
Chronic Cough participants in Sequence B were randomized to receive gefapixant 100 mg in treatment Period 1, then placebo in treatment Period 2.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 6.09 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 8.58 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 14.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Average of 1, 3, and 5 hours post-dosePopulation: The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to capsaicin challenge.
The concentration of capsaicin inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of capsaicin for cough challenge were 0.3 micromoles (µM), 1 µM, 3 µM, 10 µM, 30 µM, 100 µM, 300 µM, and 1000 µM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of capsaicin with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Cough Reflex Sensitivity to Capsaicin in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C2 Response to Capsaicin (Periods 1 & 2)
|
3.05 natural log (µM)
Interval 2.6 to 3.5
|
3.04 natural log (µM)
Interval 2.6 to 3.5
|
1.72 natural log (µM)
Interval 1.3 to 2.1
|
1.41 natural log (µM)
Interval 1.0 to 1.8
|
|
Cough Reflex Sensitivity to Capsaicin in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C5 Response to Capsaicin (Periods 1 & 2)
|
4.46 natural log (µM)
Interval 3.9 to 5.0
|
4.68 natural log (µM)
Interval 4.1 to 5.3
|
2.31 natural log (µM)
Interval 1.9 to 2.8
|
2.05 natural log (µM)
Interval 1.6 to 2.5
|
PRIMARY outcome
Timeframe: Average of 1, 3, and 5 hours post-dosePopulation: The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to citric acid challenge.
The concentration of citric acid inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of citric acid for cough challenge were 1 millimoles (mM), 3 mM, 10 mM, 30 mM, 100 mM, 300 mM, 1 M, and 3 M. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of citric acid with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Cough Reflex Sensitivity to Citric Acid in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C2 Response to Citric Acid (Periods 1 & 2)
|
6.16 natural log (mM)
Interval 5.6 to 6.8
|
5.61 natural log (mM)
Interval 5.0 to 6.2
|
4.07 natural log (mM)
Interval 3.6 to 4.6
|
3.84 natural log (mM)
Interval 3.3 to 4.3
|
|
Cough Reflex Sensitivity to Citric Acid in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C5 Response to Citric Acid (Periods 1 & 2)
|
7.12 natural log (mM)
Interval 6.4 to 7.8
|
6.82 natural log (mM)
Interval 6.1 to 7.6
|
4.74 natural log (mM)
Interval 4.2 to 5.2
|
4.46 natural log (mM)
Interval 4.0 to 5.0
|
PRIMARY outcome
Timeframe: Average of 1, 3, and 5 hours post-dosePopulation: The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to ATP challenge.
The concentration of ATP inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of ATP for cough challenge were 0.1 mM, 0.3 mM, 1 mM, 3 mM, 10 mM, 30 mM, 100 mM, and 300 mM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of ATP with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Cough Reflex Sensitivity to ATP in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C5 Response to ATP (Periods 1 & 2)
|
5.61 natural log (mM)
Interval 5.3 to 5.9
|
4.73 natural log (mM)
Interval 4.3 to 5.1
|
3.52 natural log (mM)
Interval 2.9 to 4.2
|
2.22 natural log (mM)
Interval 1.6 to 2.9
|
|
Cough Reflex Sensitivity to ATP in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C2 Response to ATP (Periods 1 & 2)
|
4.79 natural log (mM)
Interval 4.0 to 5.6
|
3.90 natural log (mM)
Interval 3.1 to 4.7
|
2.90 natural log (mM)
Interval 2.3 to 3.5
|
1.36 natural log (mM)
Interval 0.8 to 2.0
|
PRIMARY outcome
Timeframe: Average of 1, 3, and 5 hours post-dosePopulation: The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to distilled water challenge.
The concentration of distilled water inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of distilled water for cough challenge were 20%, 40%, 60%, 80%, and 100%. The Measure Type is least-squares mean in natural log scale. The number of coughs generated in 1 minute of exposure was recorded. The challenge agent was prepared by dilution of distilled water with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Cough Reflex Sensitivity to Distilled Water in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C2 Response to Distilled Water (Periods 1 & 2)
|
4.72 natural log (percent concentration [%])
Interval 4.6 to 4.8
|
4.34 natural log (percent concentration [%])
Interval 4.2 to 4.4
|
4.42 natural log (percent concentration [%])
Interval 4.3 to 4.5
|
4.12 natural log (percent concentration [%])
Interval 4.0 to 4.2
|
|
Cough Reflex Sensitivity to Distilled Water in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)
C5 Response to Distilled Water (Periods 1 & 2)
|
4.85 natural log (percent concentration [%])
Interval 4.6 to 5.1
|
4.61 natural log (percent concentration [%])
Interval 4.4 to 4.8
|
4.51 natural log (percent concentration [%])
Interval 4.4 to 4.6
|
4.24 natural log (percent concentration [%])
Interval 4.1 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and one hour after the final cough challenge on treatment daysPopulation: The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough severity.
Chronic cough participants completed a visual analogue scale (VAS) to record cough severity, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. This was a 100mm VAS of cough severity from 'No Cough' (0) up to 'Worst Cough' (100). Participants were instructed to draw a line on the scale to indicate how severe they felt their cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in cough severity.
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=24 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=24 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)
|
-26.2 Scores on a scale
Interval -36.2 to -16.2
|
-8.2 Scores on a scale
Interval -18.7 to 2.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and one hour after final cough challenge on treatment daysPopulation: The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of urge to cough.
Chronic cough participants completed a VAS to record the severity of their urge to cough, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. Participants marked the 100mm VAS at the extremes as 'No urge-to-cough' (0) and 'Worst urge-to-cough' (100). Participants were instructed to draw a single vertical line on the scale to indicate how severe their urge to cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in urge to cough.
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=24 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=24 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Change From Baseline in Urge to Cough VAS After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)
|
-29.8 Scores on a scale
Interval -38.9 to -20.7
|
-11.7 Scores on a scale
Interval -20.9 to -2.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and for 24 hours after cough challenge on treatment daysPopulation: The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough frequency.
An ambulatory cough recording device recorded all sounds chronic cough participants made during cough monitoring to measure the change from baseline in objective cough frequency on the treatment days. A negative change from Baseline was considered to indicate improvement in cough frequency
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=24 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=24 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Change From Baseline in Cough Frequency After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)
|
-7.7 Counts/hr
Interval -10.1 to -5.3
|
-4.1 Counts/hr
Interval -6.5 to -1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 18Population: The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of AE occurrence.
A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who had at least 1 adverse event (AE) over 4 days of treatment (including washout periods) in addition to 14 days (+3 days) until a post-treatment follow-up visit. An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an AE. The percentage of participants in any treatment group with at least 1 AE was assessed.
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced One or More Adverse Events During Study Treatment and Follow up
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
95.8 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 4Population: The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of discontinuation due to an AE.
A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who discontinued from the study due to an AE. The percentage of participants who discontinued from the study due to an AE was assessed for days 1-4.
Outcome measures
| Measure |
Gefapixant 100 mg/Healthy
n=12 Participants
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 Participants
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 Participants
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Gefapixant 100 mg/Healthy
Placebo/Healthy
Gefapixant 100 mg/Chronic Cough
Placebo/Chronic Cough
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gefapixant 100 mg/Healthy
n=12 participants at risk
Healthy participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Healthy
n=12 participants at risk
Healthy participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
Gefapixant 100 mg/Chronic Cough
n=24 participants at risk
Chronic Cough participants received a single dose of gefapixant 100 mg in Period 1 or Period 2, with crossover to or from placebo following a minimum 48-hour washout.
|
Placebo/Chronic Cough
n=24 participants at risk
Chronic Cough participants received a single dose of placebo in Period 1 or Period 2, with crossover to or from gefapixant 100 mg following a minimum 48-hour washout.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
4/12 • Number of events 4 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
25.0%
6/24 • Number of events 6 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
25.0%
3/12 • Number of events 3 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
16.7%
4/24 • Number of events 6 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
8.3%
2/24 • Number of events 2 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
|
Gastrointestinal disorders
Oral disorder
|
16.7%
2/12 • Number of events 2 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Gastrointestinal disorders
Paraesthesia oral
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
16.7%
4/24 • Number of events 6 • Up to Day 18
|
8.3%
2/24 • Number of events 2 • Up to Day 18
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Up to Day 18
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Nervous system disorders
Ageusia
|
50.0%
6/12 • Number of events 6 • Up to Day 18
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
29.2%
7/24 • Number of events 7 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
8.3%
2/24 • Number of events 2 • Up to Day 18
|
4.2%
1/24 • Number of events 1 • Up to Day 18
|
|
Nervous system disorders
Dysgeusia
|
75.0%
9/12 • Number of events 9 • Up to Day 18
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
66.7%
16/24 • Number of events 16 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up to Day 18
|
25.0%
3/12 • Number of events 3 • Up to Day 18
|
25.0%
6/24 • Number of events 6 • Up to Day 18
|
8.3%
2/24 • Number of events 2 • Up to Day 18
|
|
Nervous system disorders
Hypogeusia
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Nervous system disorders
Somnolence
|
16.7%
2/12 • Number of events 2 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/12 • Up to Day 18
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
8.3%
2/24 • Number of events 2 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
8.3%
1/12 • Number of events 1 • Up to Day 18
|
0.00%
0/12 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
0.00%
0/24 • Up to Day 18
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The contents of this protocol and any amendments and results obtained during the course of this study will be kept confidential by the Investigator(s), the Investigator's staff, and IRB. No data collected as part of this study will be utilized in any written work, including publications, without the written consent of Sponsor. These obligations shall in no way diminish such obligations as set forth in the Confidentiality Agreement between the Sponsor and the Investigator(s).
- Publication restrictions are in place
Restriction type: OTHER