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NCT03048448 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target

NCT03048448: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT03048448 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03048448, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study Summary

This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.

Primary Outcome

AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

Interventions

  • DRUG Fevipiprant

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2017-05-31
Est. Completion 2019-04-22
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03048448 record still lists

NCT03048448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).

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

NCT03048448 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03048448 about?

NCT03048448 is a clinical study titled "Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects". This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.

What is the current status of trial NCT03048448?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2017-05-31. Estimated completion is 2019-04-22.

What interventions are being tested in trial NCT03048448?

The interventions under investigation include: Fevipiprant (DRUG).

Who is sponsoring clinical trial NCT03048448?

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

How this trial's enrollment target compares

Where NCT03048448's enrollment target sits among peer trials

42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03048448, the US trial registry maintained by the National Library of Medicine. NCT03048448 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.