A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Gefapixant
Intervention description: Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This study assesses the tolerability of a single dose of gefapixant (AF-219) in participants
      with idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150
      mg dose of gefapixant and undergo tolerability and PK assessments.
    

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

          -  Women of child-bearing potential must use 2 forms of an 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, 1 of which must be a barrier method, and make no donation of
             sperm 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 antihypertensive agent within 4 weeks prior to the day
             of dosing (Day 1) or during the study

          -  History of upper respiratory tract infection within 4 weeks of the day of dosing (Day
             1)

          -  Requiring concomitant therapy with prohibited medications

          -  Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2

          -  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,
             fundoplication, 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

          -  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 and, in the judgment of the Investigator or Sponsor, would make the
             subject inappropriate for entry into this trial