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Food Effect Study of AG120 in Healthy Subjects

NCT02579707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-11-29

No results posted yet for this study

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

DRUG

AG120

AG120 in fed and fasted conditions. Part 2- AG120 single dose exposure

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sam Agresta, MD · Agios Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579707 on ClinicalTrials.gov