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Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma

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ClinicalTrials.gov Identifier: NCT03650400
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 27, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date June 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Plasma concentration of fevipiprant at steady state (ss), after at least four consecutive days of dosing)) by area under the curve (AUC0-24h,ss) [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Area under the curve (AUC0-24h,ss), steady state following drug administration
  • Maximum plasma concentration of fevipiprant at steady state (ss), after at least four consecutive days of dosing)) by Cmax,ss [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Maximum plasma concentration (Cmax,ss) steady state following drug administration.
  • Plasma concentration at steady state (ss), after at least four consecutive days of dosing)) by oral clearance (CL/F) [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Oral clearance (CL/F), steady state following drug administration.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Plasma concentration of fevipiprant by area under the curve (AUC0-24h,ss) [ Time Frame: 8 days ]
    Area under the curve (AUC0-24h,ss), steady state day 8 following drug administration
  • Maximum plasma concentration of fevipiprant by Cmax,ss [ Time Frame: 8 days ]
    Maximum plasma concentration (Cmax,ss) steady state day 8 following drug administration
  • Plasma concentration by oral clearance (CL/F) [ Time Frame: 8 days ]
    Oral clearance (CL/F), steady state day 8 following drug administration
Change History Complete list of historical versions of study NCT03650400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Pharmacokinetics of the metabolite CCN362 by AUC0-24h,ss [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) at steady state.
  • Pharmacokinetics of the metabolite CCN362 by Cmin,ss [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
  • Pharmacokinetics of the metabolite CCN362 by Cmax,ss [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state
  • Pharmacokinetics of the metabolite CCN362 by CL/F [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by oral clearance (CL/F) at steady state
  • Pharmacokinetics of the metabolite CCN362 by Tmax,ss [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
  • Urinary excretion of fevipiprant and CCN362 [ Time Frame: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. ]
    CLr, amount and fraction of dose excreted over the PK collection interval at steady state
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Pharmacokinetics of the metabolite CCN362 by AUC0-24h,ss [ Time Frame: 8 days ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) on day 8
  • Pharmacokinetics of the metabolite CCN362 by Cmin,ss [ Time Frame: 8 days ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) on day 8
  • Pharmacokinetics of the metabolite CCN362 by Cmax,ss [ Time Frame: 8 days ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) on day 8
  • Pharmacokinetics of the metabolite CCN362 by CL/F [ Time Frame: 8 days ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by oral clearance (CL/F) on day 8
  • Pharmacokinetics of the metabolite CCN362 by Tmax,ss [ Time Frame: 8 days ]
    Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) on day 8
  • Urinary excretion of fevipiprant and CCN362 [ Time Frame: 8 days ]
    CLr, amount and fraction of dose excreted over the PK collection interval on day 8
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
Official Title  ICMJE A Multicenter, Open-label, 8 Day Treatment Study to Assess the Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to <12 Years With Asthma
Brief Summary The purpose of this study is 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 will be obtained.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Fevipiprant
Chewable tablet
Other Name: QAW039
Study Arms  ICMJE Experimental: Fevipiprant
Fevipiprant Cohort A; Fevipiprant Cohort B; Chewable tablet
Intervention: Drug: Fevipiprant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2020
Estimated Primary Completion Date June 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03650400
Other Study ID Numbers  ICMJE CQAW039B2201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP