A Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Subjects

Trial Profile

A Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Aug 2017

At a glance

  • Drugs AL 335 (Primary) ; Moxifloxacin; Odalasvir; Simeprevir
  • Indications Hepatitis C
  • Focus Pharmacodynamics
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 11 Aug 2017 Planned number of patients changed from 105 to 140.
    • 11 Aug 2017 Planned End Date changed from 20 Oct 2017 to 23 Nov 2017.
    • 11 Aug 2017 Planned primary completion date changed from 17 Oct 2017 to 23 Nov 2017.
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