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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 : Terminated (Company Decision)
First Posted : August 28, 2018
Results First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fevipiprant Phase 2

Detailed Description:
The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years. The results of this study would have supported 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. Based on evaluation of the fevipiprant asthma development program in the recently completed studies (CQAW039A2307/ CQAW039A2314) in the adult population (the analyses of these studies did not meet the clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses [i.e. 150 mg/ 450 mg]), Novartis decided to discontinue this study (CQAW039B2201).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : January 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Cohort A Fevipiprant 75 mg
QAW039 75 mg Chewable tablet
Drug: Fevipiprant
Chewable tablet
Other Name: QAW039

Experimental: Cohort B Feviprant 375 mg
QAW039 375 mg Chewable tablet
Drug: Fevipiprant
Chewable tablet
Other Name: QAW039




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Pharmacokinetics of Fevipiprant 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 fevipiprant by oral clearance (CL/F) at steady state

  2. Pharmacokinetics of Fevipiprant 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 fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state

  3. Urinary Excretion of Fevipiprant [ 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, of fevipiprant

  4. Pharmacokinetics of Fevipiprant 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 fevipiprant by minimum plasma concentration (Cmin,ss) at steady state

  5. 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.

  6. 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

  7. 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

  8. 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

  9. Urinary Excretion of the Metabolite, 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, of the metabolite, CCN362



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650400


Locations
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United States, California
Novartis Investigative Site
Orange, California, United States, 92868
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Novartis Investigative Site
Columbia, Missouri, United States, 65203
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28277
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45229
Novartis Investigative Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Novartis Investigative Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Novartis Investigative Site
Medford, Oregon, United States, 97504
United States, Texas
Novartis Investigative Site
Boerne, Texas, United States, 78006
Novartis Investigative Site
El Paso, Texas, United States, 79903
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United Kingdom
Novartis Investigative Site
London, United Kingdom, SE5 8AD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] February 28, 2020
Study Protocol  [PDF] February 13, 2019

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03650400    
Other Study ID Numbers: CQAW039B2201
First Posted: August 28, 2018    Key Record Dates
Results First Posted: July 20, 2020
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Fevipiprant,
GINA 2018,
Pediatrics
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases