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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03397329 | Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults | PHASE1 | COMPLETED | 26 | — | — | Oct 3, 2017 | Nov 13, 2017 | Jan 12, 2018 | 1 | United States |
AG-348 Maximum Plasma Concentration
AG-348 Area Under the Curve
| Arm | Type | Description |
|---|---|---|
| Sequence A | ACTIVE_COMPARATOR | - |
| Sequence B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AG-348 Sequence A | DRUG | 1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) |
| AG-348 Sequence B | DRUG | 1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) |
Inclusion Criteria: * Be a male or female aged 18 to 55 years, inclusive. * Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening. * Agrees to abstain from any alcohol consumption. * Be healthy overall with no clinically significant medical abnormalities, as determined by the Investig...