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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 )

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Estimated Primary Completion Date : June 23, 2020
Estimated Study Completion Date : July 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Fevipiprant
Fevipiprant Cohort A; Fevipiprant Cohort B; 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 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
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United States, California
Novartis Investigative Site Recruiting
Orange, California, United States, 92868
United States, Georgia
Novartis Investigative Site Recruiting
Stockbridge, Georgia, United States, 30281
United States, Minnesota
Novartis Investigative Site Recruiting
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Novartis Investigative Site Recruiting
Columbia, Missouri, United States, 65203
United States, North Carolina
Novartis Investigative Site Recruiting
Charlotte, North Carolina, United States, 28277
United States, Oklahoma
Novartis Investigative Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
Novartis Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Novartis Investigative Site Recruiting
Medford, Oregon, United States, 97504
United States, Texas
Novartis Investigative Site Recruiting
Boerne, Texas, United States, 78006
Novartis Investigative Site Recruiting
El Paso, Texas, United States, 79903
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03650400     History of Changes
Other Study ID Numbers: CQAW039B2201
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
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
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs