Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)
Condition: Chronic Cough
MeSH terms: Cough
Intervention: Gefapixant 45 mg; Placebo
Intervention description: Gefapixant 45 mg (film-coated tablet) to be administered orally BID; Placebo (film-coated tablet) matching gefapixant to be administered orally BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Japanese adult participants with refractory or unexplained chronic cough will be randomized to 1 of 2 treatment groups: gefapixant 45 mg twice daily (BID), or placebo BID.
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of
      gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic
      cough.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chest radiograph or computed tomography scan of the thorax (within 5 years of
             Screening/Visit 1 and after the onset of chronic cough) not demonstrating any
             abnormality considered to be significantly contributing to the chronic cough or any
             other clinically significant lung disease in the opinion of the principal investigator
             or the sub-investigator.

          -  Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or
             unexplained chronic cough.

          -  For female participants, is a female who is not pregnant, not breastfeeding, not of
             childbearing potential, or agrees to follow contraceptive guidance

          -  Provides written informed consent and is willing and able to comply with the study
             protocol (including use of the digital cough recording device and completion of study
             questionnaires)

        Exclusion Criteria:

          -  Is a current smoker or has given up smoking within 12 months of Screening, or is a
             former smoker with a pack-year history >20 pack-years

          -  Has a history of upper or lower respiratory tract infection or recent clinically
             significant change in pulmonary status

          -  Has a history of chronic bronchitis

          -  Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an
             ACEI within 3 months of Screening

          -  Has a history of malignancy ≤5 years

          -  Has a screening systolic blood pressure >160 millimeters of mercury (mmHg) or a
             diastolic blood pressure >90 mm Hg

          -  Has a history of cutaneous adverse drug reaction to sulfonamides with or without
             systemic symptoms or history of anaphylaxis to sulfonamides

          -  Is a user of recreational or illicit drugs or has had a recent history of drug or
             alcohol abuse or dependence

          -  Has a known allergy/sensitivity or contraindication to gefapixant

          -  Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of
             gefapixant

          -  Has previously received gefapixant or is currently participating in or has
             participated in an interventional clinical study