Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-01-22

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A Fevipiprant 75 mg

QAW039 75 mg Chewable tablet

Group Type EXPERIMENTAL

Fevipiprant

Intervention Type DRUG

Chewable tablet

Cohort B Feviprant 375 mg

QAW039 375 mg Chewable tablet

Group Type EXPERIMENTAL

Fevipiprant

Intervention Type DRUG

Chewable tablet

Interventions

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Fevipiprant

Chewable tablet

Intervention Type DRUG

Other Intervention Names

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QAW039

Eligibility Criteria

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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).

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No