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An Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With End-stage Renal Disease on Hemodialysis and Optionally in Patients With Severe to Moderate and Mild Renal Impairment Compared to Matched Healthy Volunteers Including a Cross-over Assessment in End-stage Renal Disease Patients on the Effect of Dialysis on Fevipiprant Pharmacokinetics

Trial Profile

An Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With End-stage Renal Disease on Hemodialysis and Optionally in Patients With Severe to Moderate and Mild Renal Impairment Compared to Matched Healthy Volunteers Including a Cross-over Assessment in End-stage Renal Disease Patients on the Effect of Dialysis on Fevipiprant Pharmacokinetics

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Oct 2018

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At a glance

  • Drugs Fevipiprant (Primary)
  • Indications Allergic asthma; Atopic dermatitis
  • Focus Pharmacokinetics
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 10 Oct 2018 Status changed from recruiting to completed.
    • 23 Jul 2018 Planned End Date changed from 16 Oct 2018 to 22 Oct 2018.
    • 23 Jul 2018 Planned primary completion date changed from 16 Oct 2018 to 22 Oct 2018.
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