A Phase I Randomized, Double-blind, Five-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of AG-519, the Relative Bioavailability of Prototype Tablet Formulations Compared With a Suspension Formulation, and to Evaluate the Pharmacokinetics of a Selected Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

Trial Profile

A Phase I Randomized, Double-blind, Five-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of AG-519, the Relative Bioavailability of Prototype Tablet Formulations Compared With a Suspension Formulation, and to Evaluate the Pharmacokinetics of a Selected Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Jul 2017

At a glance

  • Drugs AG 519 (Primary)
  • Indications Haemolytic anaemia
  • Focus Adverse reactions
  • Sponsors Agios Pharmaceuticals
  • Most Recent Events

    • 15 Dec 2016 According to an Agios Pharmaceuticals media release, company has discontinued the development of AG-519 following FDA feedback. Company has also withdrew its investigational new drug (IND) application following a verbal notification of a clinical hold from the U.S. Food and Drug Administration (FDA).
    • 15 Dec 2016 Status changed from recruiting to discontinued, as per an Agios Pharmaceuticals media release.
    • 06 Dec 2016 Results of first 4 cohorts of the multiple ascending dose phase (n=32) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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