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
Status:
Discontinued
Phase of Trial:
Phase I
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs AG 519 (Primary)
- Indications Haemolytic anaemia
- Focus Adverse reactions
- Sponsors Agios Pharmaceuticals
- 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