Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 1420 for:    Area Under Curve AND tablet

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03650400
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
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

Layout table for study information
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
Estimated Study Start Date : November 8, 2018
Estimated Primary Completion Date : January 28, 2020
Estimated Study Completion Date : January 28, 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 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

  2. Maximum plasma concentration of fevipiprant by Cmax,ss [ Time Frame: 8 days ]
    Maximum plasma concentration (Cmax,ss) steady state day 8 following drug administration

  3. Plasma concentration by oral clearance (CL/F) [ Time Frame: 8 days ]
    Oral clearance (CL/F), steady state day 8 following drug administration


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.
  • 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).
  • Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.

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
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals novartis.email@novartis.com

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
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: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
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