NCT03569033终止2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Awake Coughs Per Hour on Day 3
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Gefapixant 45 mg BID
Experimental
Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.
干预措施: Gefapixant (Drug)
Placebo BID
Placebo Comparator
Participants will receive a matching placebo tablet BID for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Awake Coughs Per Hour on Day 3
时间窗: Day 3
Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.
次要结局
- Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3(Baseline and Day 3)
- Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3(Baseline and Day 3)
- Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)(Up to Day 7)
- Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3(Baseline and Day 3)
- Percentage of Participants Who Experienced One or More Adverse Events (AEs)(Up to 21 days)
研究者
研究点 (1)
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