Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02218346 | Food Effect Study of AG-221 in Healthy Male Subjects | PHASE1 | COMPLETED | 30 | — | — | Aug 1, 2014 | Mar 1, 2015 | Dec 14, 2015 | 1 | United States |
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...