Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Fevipiprant
Intervention description: Chewable tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: There will be 2 treatment dose cohorts studied (fevipiprant dose A once daily and one higher dose selected based on PK obtained at dose A mg/day, fevipiprant dose B once daily). Within each dose cohort, subjects will be stratified approximately 1:1 ratio into 2 age groups: ages 6 to < 9 years and ages 9 to < 12 years.
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Fevipiprant,; GINA 2018,; Pediatrics

Summary:

      The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant (QAW039)
      delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years with
      asthma. The results of this study will support the identification of a fevipiprant dose for
      subsequent pediatric efficacy studies aiming to provide an exposure similar to that of the
      to-be marketed adult/adolescent dose. In addition, the first data on safety and tolerability
      of fevipiprant in this age group was obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children

          -  Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and
             assent by the pediatric patient (depending on local requirements) must be obtained
             before any study-specific assessment is performed.

          -  Confirmed/documented diagnosis of asthma, as defined by national or international
             asthma guidelines for at least 6 months prior to study enrollment.

          -  Subjects using asthma rescue medication (e.g. SABA) without asthma controller therapy
             or patients receiving daily treatment with a stable dose ICS (with or without
             additional controller such as long-acting β-agonists (LABA), long-acting muscarinic
             antagonists (LAMA)) for at least 4 weeks prior to Treatment Visit (Day 1).

          -  Subjects must be able to attend study visits as per Study Visit Assessment Schedule
             (Section 8) which includes 8 to 9 hours in the clinic/home on the day of End of
             Treatment Visit and have blood draws as scheduled in the study.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of enrollment, or (within 30
             days (for small molecules)/until the expected pharmacodynamic effect has returned to
             baseline (for biologics)), whichever is longer.

          -  Subject is unable to ingest banana and/or yogurt

          -  History of hypersensitivity to any of the study drugs or its excipients or to drugs of
             similar chemical classes.

          -  History of chronic lung disease other than asthma such as and not limited to,
             sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other
             infection (including active tuberculosis or atypical mycobacterial disease).

          -  History of active bacterial, viral or fungal infection within 6 weeks of Treatment
             Visit (Day 1).