Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG-348 Sequence A · 1 trial · 1 indication
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...
AG-348 Sequence A is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in clinical development to evaluate its properties in healthy adults.
AG-348 Sequence A is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AGIO.
AG-348 Sequence A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed.
AG-348 Sequence A was studied in a completed Phase 1 trial, NCT03397329, which evaluated the relative bioavailability and safety of the AG-348 tablet and capsule formulations in healthy adults. The trial enrolled 26 participants in the United States.
AG-348 Sequence A is a formulation of AG-348, the drug candidate developed by Agios Pharmaceuticals. The trial NCT03397329 compares the tablet and capsule formulations of AG-348 to assess their relative bioavailability and safety.