A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation

Trial Profile

A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2016

At a glance

  • Drugs Granisetron (Primary) ; Granisetron (Primary) ; Moxifloxacin
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors Heron Therapeutics
  • Most Recent Events

    • 18 Apr 2016 According to a Heron Therapeutics media release, the US FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.
    • 16 Oct 2012 The US FDA accepted a New Drug Application for granisetron, according to an A.P. Pharma media release.
    • 26 Mar 2012 Status changed from active, no longer recruiting to completed, according to an A.P. Pharma media release.
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