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Completed Phase 1 Interventional Accepts healthy volunteers

Food Effect Study of AG-221 in Healthy Male Subjects

ClinicalTrials.gov ID: NCT02218346

Public ClinicalTrials.gov record NCT02218346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 1:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Two-Way Crossover Study to Assess the Pharmacokinetics and Safety of a Single Dose of AG-221 in Healthy Male Subjects When Administered Under Fed and Fasted Conditions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02218346
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Enrollment
30 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 56 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2014
Primary completion
Nov 30, 2014
Completion
Feb 28, 2015
Last update posted
Dec 13, 2015

2014 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Not listed Baltimore Maryland 21225

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02218346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 13, 2015 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02218346 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →