Trial · NCT01993329
A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)
NCT01993329, Phase 2, Completed, Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009). Trials, record NCT01993329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01993329
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)
- NCT number
- NCT01993329
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Asthma
- Interventions
- Gefapixant 50 mg, Gefapixant 300 mg, Placebo to mimic 50 mg tablets, Placebo to mimic 300 mg tablets
- First posted
- 2013-11-25
- Last updated
- 2021-02-03
- Other registries' IDs
- eudract:2013-003566-13
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provocative Concentration (PC20) After Methacholine Challenge | Screening (Day -21 to Day -1) and Day 3 | The provocative concentration (PC) of inhaled methacholine required to reduce forced expiratory volume in 1 second (FEV1) by 20% (PC20) was calculated from the methacholine challenge at screening and 2 hours (+15 minutes) post dose on Day 3 of each Treatment Period using a five-breath dosimeter method. The primary endpoint was the methacholine PC20 value normalized by means of a log (base 2) transformation, at 2 dose levels compared with placebo in participants with asthma following provocation with methacholine. |
| Secondary | Highest FEV1 After Methacholine Challenge | Screening (Day -21 to Day -1) and Day 3 | Serial FEV1 was measured post inhalation of methacholine challenges for 90 minutes. The highest FEV1 at 5, 15, 30, 45, 60, and 90 minutes following methacholine challenge were evaluated for each subject. The minimum highest FEV1 was derived using the first three available measures that cover the first 30 minutes after the challenge. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Provocative Concentration (PC20) After Methacholine Challenge | Screening (Day -21 to Day -1) and Day 3 | Analysis population included all randomized participants who received at least 1 dose of study medication and had any post-dose efficacy evaluations for a given Treatment Period and who completed all 3 Treatment Periods. | log [mg/mL] | GEOMETRIC_MEAN |
| SECONDARY | Highest FEV1 After Methacholine Challenge | Screening (Day -21 to Day -1) and Day 3 | Analysis population included all randomized participants who received at least 1 dose of study medication and had any post-dose efficacy evaluations for a given Treatment Period and who completed all 3 Treatment Periods. | Liters | MEAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Provocative Concentration (PC20) After Methacholine Challenge | Gefapixant 50 | 0.91 | Geometric Coefficient of Variation 214.4 | log [mg/mL] | |
| Provocative Concentration (PC20) After Methacholine Challenge | Gefapixant 300 | 0.84 | Geometric Coefficient of Variation 181.0 | log [mg/mL] | |
| Provocative Concentration (PC20) After Methacholine Challenge | Placebo | 0.82 | Geometric Coefficient of Variation 260.1 | log [mg/mL] | |
| Highest FEV1 After Methacholine Challenge | Screening | + 5 minutes | 2.44 | Standard Deviation 0.66 | Liters |
| Highest FEV1 After Methacholine Challenge | Gefapixant 50 | + 5 minutes | 2.53 | Standard Deviation 0.70 | Liters |
| Highest FEV1 After Methacholine Challenge | Gefapixant 300 | + 5 minutes | 2.43 | Standard Deviation 0.71 | Liters |
| Highest FEV1 After Methacholine Challenge | Placebo | + 5 minutes | 2.54 | Standard Deviation 0.75 | Liters |
| Highest FEV1 After Methacholine Challenge | Screening | +15 minutes | 2.69 | Standard Deviation 0.75 | Liters |
| Highest FEV1 After Methacholine Challenge | Gefapixant 50 | +15 minutes | 2.72 | Standard Deviation 0.80 | Liters |
| Highest FEV1 After Methacholine Challenge | Gefapixant 300 | +15 minutes | 2.67 | Standard Deviation 0.83 | Liters |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Gefapixant 50 mg>Gefapixant 300 mg>Placebo | 3 | |
| Period 1 | STARTED | Gefapixant 50 mg>Placebo>Gefapixant 300 mg | 4 | |
| Period 1 | STARTED | Gefapixant 300 mg>Gefapixant 50 mg>Placebo | 3 | |
| Period 1 | STARTED | Gefapixant 300 mg>Placebo>Gefapixant 50 mg | 3 | |
| Period 1 | STARTED | Placebo> Gefapixant 50 mg>Gefapixant 300 mg | 3 | |
| Period 1 | STARTED | Placebo> Gefapixant 300 mg>Gefapixant 50 mg | 4 | |
| Period 1 | COMPLETED | Gefapixant 50 mg>Gefapixant 300 mg>Placebo | 3 | |
| Period 1 | COMPLETED | Gefapixant 50 mg>Placebo>Gefapixant 300 mg | 4 | |
| Period 1 | COMPLETED | Gefapixant 300 mg>Gefapixant 50 mg>Placebo | 3 | |
| Period 1 | COMPLETED | Gefapixant 300 mg>Placebo>Gefapixant 50 mg | 3 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Irritable bowel syndrome | Gastrointestinal disorders | Gefapixant 50 mg | 1 | 19 | 1 |
| other | Irritable bowel syndrome | Gastrointestinal disorders | Gefapixant 300 mg | 0 | 19 | 0 |
| other | Irritable bowel syndrome | Gastrointestinal disorders | Placebo | 0 | 20 | 0 |
| other | Nausea | Gastrointestinal disorders | Gefapixant 50 mg | 0 | 19 | 0 |
| other | Nausea | Gastrointestinal disorders | Gefapixant 300 mg | 3 | 19 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 20 | 1 |
| other | Thirst | General disorders | Gefapixant 50 mg | 1 | 19 | 1 |
| other | Thirst | General disorders | Gefapixant 300 mg | 1 | 19 | 1 |
| other | Thirst | General disorders | Placebo | 0 | 20 | 0 |
| other | Soft tissue injury | Injury, poisoning and procedural complications | Gefapixant 50 mg | 1 | 19 | 1 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefapixant 50 mg | 0 | 20 |
| Total, all-cause mortality | Gefapixant 300 mg | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Gefapixant 50 mg | 16 | 19 |
| Total, other adverse events | Gefapixant 300 mg | 19 | 19 |
| Total, other adverse events | Placebo | 8 | 20 |
| Total, serious adverse events | Gefapixant 50 mg | 0 | 19 |
| Total, serious adverse events | Gefapixant 300 mg | 0 | 19 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01993329
GET https://conductscience.org/api/trials/v1/NCT01993329/results?page=2