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Food Effect Study of AG-221 in Healthy Male Subjects

NCT02218346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-14

No results posted yet for this study

Summary

AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment.

Administration of oral drugs with food may change the absorption of drugs, and it is therefore useful to characterize the effect of food early in drug development.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AG221

AG221 in fed and fasted conditions

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Samuel Agresta, MD, MPH &TM · Agios Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-12-31
Completion
2015-03-31

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 NCT02218346 on ClinicalTrials.gov