drugset / Trial / NCT03087942

Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects

NCT03087942

Phase 1 Completed 45 enrolled Novartis Pharmaceuticals
NaParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-07-05
Primary completion
2018-08-07
Completion
2018-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject fevipiprant Small molecule 450 mg