NCT02579707

Food Effect Study of AG120 in Healthy Subjects

A Phase 1, Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of Food On AG-120 Pharmacokinetics Following Single Oral Dose Administration To Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design. PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AG120	AG120 in fed and fasted conditions. Part 2- AG120 single dose exposure

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2015-10-20
• Last updated: 2016-11-29

Locations

1 site across 1 country: United States