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NCT03087942 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
A Phase 1 study of Renal Insufficiency, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 2
- Study locations
NCT03087942: Completed Phase 1 study of Renal Insufficiency, sponsored by Novartis Pharmaceuticals.
NCT03087942 is a Phase 1 study of Renal Insufficiency that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 45 participants, below the 99-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03087942, a Phase 1 study of Renal Insufficiency, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 2
- Study locations
Study Summary
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population. The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.
Primary Outcome
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Conditions Studied
Interventions
- DRUG QAW039
- DRUG QAW39A
- DRUG QAW39A2107
Study Locations (2)
Florida
- Novartis Investigative Site - Orlando
Other
- Novartis Investigative Site - Grünstadt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2018-08-07 |
| Phase | Phase 1 |
What the finished NCT03087942 record still lists
NCT03087942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 99-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Renal Insufficiency appearing as the primary indexed condition, and to 3 interventions - of which QAW039 is the first listed.
NCT03087942 reports a single indexed study location in Florida, Other.
Frequently Asked Questions
What is clinical trial NCT03087942 about?
NCT03087942 is a clinical study titled "Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects". The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population. The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the proced...
What is the current status of trial NCT03087942?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2017-07-05. Estimated completion is 2018-08-07.
What conditions does trial NCT03087942 study?
This clinical trial studies the following conditions: Renal Insufficiency.
What interventions are being tested in trial NCT03087942?
The interventions under investigation include: QAW039 (DRUG), QAW39A (DRUG), QAW39A2107 (DRUG).
Who is sponsoring clinical trial NCT03087942?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03087942 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03087942's enrollment target sits among peer trials
45 9th of 22 higher than 14 of 22 other Renal Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Insufficiency 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.
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