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A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects

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Trial Profile

A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 May 2021

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At a glance

  • Drugs Isavuconazole (Primary) ; Moxifloxacin
  • Indications Aspergillosis; Candidiasis; Zygomycosis
  • Focus Adverse reactions
  • Acronyms SECURE
  • Sponsors Astellas Pharma

    • Most Recent Events

    • 29 Apr 2021 Results of post-hoc analysis of two studies (SECURE & VITAL) published in the Clinical Infectious Diseases.
    • 19 Nov 2020 Data were used from SECURE and VITAL studies to assess Cost-Effectiveness of Isavuconazole in the Treatment of Invasive Fungal Infections in Portugal presented at the 23rd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 12 Nov 2018 Results assessing exposure-response relationships of isavuconazole plasma concentrations in the Phase 3 SECURE trial published in the Journal of Antimicrobial Chemotherapy
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