Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).

Official Title
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A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection

Conditions
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Acute Cough

Intervention / Treatment
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* Drug: Gefapixant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health Susceptible to human rhinovirus type 16 (HRV-16) Male or non-pregnant and non-breast feeding female If female of reproductive potential, agrees to use 1 form of acceptable birth control Exclusion Criteria: Donated blood within 56 days or donated plasma within 7 days prior to dosing History of significant multiple and/or severe allergies Recent history of respiratory tract infection History of cancer Body mass index <18 kg/m^2 or ≥40 kg/m^2 History of major surgery or loss of 1 unit of blood History of allergic reaction to sulfonamides Received medications within 14 days prior to randomization Significantly abnormal laboratory tests at Screening Current smoker, smoked within 5 years of Screening, or significant past smoking history History of alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefapixant 45 mg BID<br>Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days. | Drug: Gefapixant<br>* Gefapixant 45 mg will be administered orally.<br>* Other names: MK-7264;|
| Placebo Comparator: Placebo BID<br>Participants will receive a matching placebo tablet BID for 7 days. | Drug: Placebo<br>* Placebo tablet matching gefapixant will be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awake Coughs Per Hour on Day 3 | Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3. | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3 | The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3. | Baseline and Day 3 | 
| Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3 | The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of today (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3. | Baseline and Day 3 | 
| Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3 | The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3. | Baseline and Day 3 | 
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 21 days | 
| Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to Day 7 |