Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03650400 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
11
Enrollment target

NCT03650400 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 11 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03650400, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
11 participants
Enrollment target

Study 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.

Interventions

  • DRUG Fevipiprant

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-05-01
Est. Completion 2020-01-22
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT03650400

The ClinicalTrials.gov registry entry for NCT03650400 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Fevipiprant is the first listed.

NCT03650400 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03650400 about?

NCT03650400 is a clinical study titled "Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma". 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 effic...

What is the current status of trial NCT03650400?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2019-05-01. Estimated completion is 2020-01-22.

What interventions are being tested in trial NCT03650400?

The interventions under investigation include: Fevipiprant (DRUG).

Who is sponsoring clinical trial NCT03650400?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.