Trials / Completed
CompletedNCT01993329
A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to Evaluate the Effect of AF-219 on Methacholine Hyper-Reactivity in Subjects With Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, single centre study in participants with asthma undergoing inhalation of methacholine and adenosine triphosphate (ATP) to assess the provocative concentration (PC20) response of two dose levels of gefapixant (AF-219) compared with placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gefapixant 50 mg | Gefapixant 50 mg tablet administered orally |
| DRUG | Gefapixant 300 mg | Gefapixant 300 mg tablet administered orally |
| DRUG | Placebo to mimic 50 mg tablets | Sugar pill manufactured to mimic gefapixant 50 mg tablets |
| DRUG | Placebo to mimic 300 mg tablets | Sugar pill manufactured to mimic gefapixant 300 mg tablets |
Timeline
- Start date
- 2013-12-16
- Primary completion
- 2014-02-20
- Completion
- 2014-02-28
- First posted
- 2013-11-25
- Last updated
- 2021-02-03
- Results posted
- 2021-02-03
Source: ClinicalTrials.gov record NCT01993329. Inclusion in this directory is not an endorsement.