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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

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: 12 Nov 2018

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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

    • 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
    • 29 Oct 2018 Results of pooled analysis evaluating the relationship of isavuconazole and voriconazole minimum inhibitory concentrations (MICs) of Aspergillus pathogens at baseline with all-cause mortality and clinical outcomes following treatment with either drug in the SECURE and VITAL trials published in the Antimicrobial Agents and Chemotherapy
    • 11 Jan 2017 Results from NCT00412893 (post hoc analysis; n=257) and NCT01565720 (n=161) studies assessing effect of isavuconazole on cardiac repolarization, published in the Clinical Pharmacology and Therapeutics.
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