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NCT02218346 · ClinicalTrials.gov registry record · Phase 1

Food Effect Study of AG-221 in Healthy Male Subjects

A Phase 1 study of Healthy Volunteers, sponsored by Agios Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT02218346: Completed Phase 1 study of Healthy Volunteers, sponsored by Agios Pharmaceuticals.

NCT02218346 is a Phase 1 study of Healthy Volunteers that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 30 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02218346, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Agios Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

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.

Primary Outcome

Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of AG-221.

Conditions Studied

Interventions

  • DRUG AG221

Study Locations (1)

Maryland

  • - Baltimore

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2014-08
Est. Completion 2015-03
Phase Phase 1
Agios Pharmaceuticals

44 total trials

What the finished NCT02218346 record still lists

NCT02218346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which AG221 is the first listed.

NCT02218346 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT02218346 about?

NCT02218346 is a clinical study titled "Food Effect Study of AG-221 in Healthy Male Subjects". 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 characteriz...

What is the current status of trial NCT02218346?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-08. Estimated completion is 2015-03.

What conditions does trial NCT02218346 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT02218346?

The interventions under investigation include: AG221 (DRUG).

Who is sponsoring clinical trial NCT02218346?

This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02218346 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy Volunteers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02218346's enrollment target sits among peer trials

30 187th of 283 higher than 87 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02218346, the US trial registry maintained by the National Library of Medicine. NCT02218346 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.