Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The only completed trial evaluated its effects in healthy male subjects.
AG221 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AGIO. The company conducted a Phase 1 study of AG221 in healthy volunteers.
AG221 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed. The drug remains investigational and has not been approved by regulatory authorities.
AG221 has one completed clinical trial, NCT02218346, titled 'Food Effect Study of AG-221 in Healthy Male Subjects.' This Phase 1 study enrolled 30 healthy male participants in the United States and was completed.
Yes, AG221 is also referred to as AG-221 in clinical trial documentation. The completed study NCT02218346 uses the name AG-221 in its title, confirming that both names refer to the same investigational drug.