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AG221 · 1 trial · 1 indication
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of AG-221.
| Arm | Type | Description |
|---|---|---|
| Treatment A (unfed) | ACTIVE_COMPARATOR | Treatment A: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, following a 10-hour overnight fast. |
| Treatment B (fed) | ACTIVE_COMPARATOR | Treatment B: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast. |
| Name | Type | Description |
|---|---|---|
| AG221 | DRUG | AG221 in fed and fasted conditions |
Inclusion Criteria: 1. Healthy adult male subjects 18 to 56 years of age, inclusive, at Screening. 2. Subjects who are able to understand and sign informed consent prior to the conduct of any protocol-specific screening procedures. 3. Subjects must be willing and able to complete all study assessme...
AG221 is an investigational small molecule developed by Agios Pharmaceuticals, Inc. (ticker AGIO). It is an IDH2-targeted agent that has been studied in a Phase 1 clinical trial. The specific disease indications for AG221 have not been publicly disclosed.
AG221 targets IDH2, a gene encoding isocitrate dehydrogenase 2. By acting on this molecular target, AG221 is designed as a targeted small molecule therapy. IDH2 is the specific molecular target associated with this investigational compound.
AG221 is being developed by Agios Pharmaceuticals, Inc., which trades under the ticker symbol AGIO. Agios is the company responsible for the development of this investigational IDH2-targeted small molecule.
AG221 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial evaluating the compound in healthy male subjects.
AG221 has been evaluated in one completed Phase 1 trial, NCT02218346, titled Food Effect Study of AG-221 in Healthy Male Subjects. This active-controlled trial enrolled 30 healthy male volunteers aged 18 years and older in the United States.
Yes, AG221 and AG-221 refer to the same investigational compound. AG-221 is the hyphenated form of the name used in the clinical trial identifier NCT02218346, while AG221 is the unhyphenated form. Both names refer to the same IDH2-targeted small molecule developed by Agios Pharmaceuticals.