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A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.

Trial Profile

A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Apr 2015

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At a glance

  • Drugs Elafibranor (Primary) ; Moxifloxacin
  • Indications Infections; Lipid metabolism disorders; Liver disorders; Pelvic inflammatory disorders; Type 2 diabetes mellitus
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Genfit
  • Most Recent Events

    • 09 Mar 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 20 Jan 2015 Planned End Date changed from 1 Aug 2014 to 1 Feb 2015 as reported by ClinicalTrials.gov.
    • 20 Jan 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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