A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)
Condition: Idiopathic Pulmonary Fibrosis; Cough
MeSH terms: Pulmonary Fibrosis; Cough; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Gefapixant; Placebo
Intervention description: Gefapixant 50 mg tablet, administered by mouth; Matching placebo to gefapixant, tablet administered by mouth
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled, crossover, dose escalation study of
      gefapixant (AF-219) in participants with Idiopathic Pulmonary Fibrosis (IPF) with persistent
      cough.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic pulmonary fibrosis diagnosis based upon the American Thoracic Society
             (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/ Latin
             American Thoracic Society (ALAT) IPF 2011 guideline

          -  Life expectancy of greater than 6 months

          -  Stable medical condition (IPF) for at least 4 weeks

          -  Self-reported history of troublesome daily cough for more than 8 weeks

          -  Score of ≥ 40mm on the Cough Severity Visual Analogue Scale (VAS) at Screening

          -  Women of child-bearing potential must use 2 forms of acceptable birth control method
             from Screening through the Follow-Up Visit

          -  Male subjects and their partners of child-bearing potential must use 2 methods of
             acceptable birth control from Screening until 3 months after the last dose of study
             drug

          -  Written informed consent

          -  Willing and able to comply with all aspects of the protocol

        Exclusion Criteria:

          -  Current smoker (i.e., within the last 30 days).

          -  Initiation of treatment with an ACE-inhibitor within 4 weeks prior to the Baseline
             Visit (Day 0) or during the study

          -  History of upper and/or lower respiratory tract infection within 4 weeks of the
             Baseline Visit (Day 0)

          -  History of opioid use for treatment of cough within 1 week of the Baseline Visit (Day
             0)

          -  Requiring prohibited medications

          -  Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2

          -  History or symptoms of renal disease or renal obstructive disease

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening (not including subjects with <3 excised basal cell carcinomas)

          -  History of a diagnosis of drug or alcohol dependency or abuse within approximately the
             last 3 years

          -  Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, any
             type of bariatric surgery, vagotomy, or bowel resection)

          -  Recent history of stroke or transient ischemic attack (within 6 months prior to
             Screening) not due to trauma, repaired vascular malformation, or aneurysm

          -  Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP)
             >90 mm Hg

          -  QTc interval >450 milliseconds in males, >470 milliseconds in females

          -  Significantly abnormal laboratory tests at Screening

          -  Breastfeeding

          -  Treatment with an investigational drug or biologic within 30 days preceding the first
             dose of study medication or plans to take another investigational drug or biologic
             within 30 days of study completion

          -  Blood donation within 56 days or plasma donation within 7 days prior to dosing

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results