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

NCT03650400 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CQAW039B2201
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma

Keywords

Fevipiprant,; GINA 2018,; Pediatrics

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing

  Area under the curve (AUC0-24h,ss), steady state following drug administration

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

• Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing

  Maximum plasma concentration (Cmax,ss) steady state following drug administration.

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

• Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing

  Oral clearance (CL/F), steady state following drug administration.

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Secondary Outcomes (9)

• Pharmacokinetics of Fevipiprant by CL/F

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

• Pharmacokinetics of Fevipiprant by Tmax,ss

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

• Urinary Excretion of Fevipiprant

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

• Pharmacokinetics of Fevipiprant by Cmin,ss

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

• Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss

  End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Study Arms (2)

Cohort A Fevipiprant 75 mg

EXPERIMENTAL

QAW039 75 mg Chewable tablet

Drug: Fevipiprant

Cohort B Feviprant 375 mg

EXPERIMENTAL

QAW039 375 mg Chewable tablet

Drug: Fevipiprant

Interventions

Fevipiprant DRUG

Chewable tablet

Also known as: QAW039

Cohort A Fevipiprant 75 mg; Cohort B Feviprant 375 mg

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

Location

Novartis Investigative Site

Columbia, Missouri, 65203, United States

Location

Novartis Investigative Site

Tulsa, Oklahoma, 74136, United States

Location

Novartis Investigative Site

Boerne, Texas, 78006, United States

Location

Novartis Investigative Site

El Paso, Texas, 79903, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com
• A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Asthma

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

882 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 28, 2018
• Study Start: May 1, 2019
• Primary Completion: December 16, 2019
• Study Completion: January 22, 2020
• Last Updated: January 13, 2026
• Results First Posted: July 20, 2020

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (6)