Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG-120 · 2 trials · 2 indications
AG-120 Cmax, derived from plasma concentration-time curves
AG-120 AUC, derived from plasma concentration-time curves
Total \[14C\]-radioactivity in whole blood and plasmafollowing oral administration of a single 500-mg (approximately 200 μCi) radiolabeled dose of AG-120 in male subjects
time of maximum observed drug concentration
Area under the curve
Estimate of the terminal elimination half-life
Total \[14C\]-radioactivity in urine, and feces (and vomitus, if applicable).
| Arm | Type | Description |
|---|---|---|
| Cohort 1A: Mild Hepatic Impairment | EXPERIMENTAL | Drug: AG-120 (Ivosidenib) A single 500 mg oral dose of AG-120 (Ivosidenib) in subjects with mild hepatic impairment(Child-Pugh Score A.) |
| Cohort 1B: Healthy Volunteers | ACTIVE_COMPARATOR | Drug: AG-120 (Ivosidenib) A single 500 mg oral dose of AG-120 (Ivosidenib) in subjects with normal hepatic function. |
| Cohort 2A: Moderate Hepatic Impairment | EXPERIMENTAL | Drug: AG-120 (Ivosidenib) A single 500 mg oral dose of AG-120 (Ivosidenib) in subjects with moderate hepatic impairment (Child-Pugh Score B.) |
| Cohort 2B: Healthy Volunteers | ACTIVE_COMPARATOR | Drug: AG-120 (Ivosidenib) A single 500 mg oral dose of AG-120 (Ivosidenib) in subjects with normal hepatic function. |
| Single group assignment | OTHER | \[14C\]-AG-120 |
| Name | Type | Description |
|---|---|---|
| AG-120 (Ivosidenib) | DRUG | Single 500 mg dose of AG-120 (Ivosidenib). |
| [14C]-AG-120 | DRUG | Labeled investigational drug |
Key Inclusion Criteria: All subjects: * Body Mass Index BMI of 19 to 40 kg/m2 (inclusive). * Willing and able to comply with all study restrictions and requirements. * Non- smoker, or uses no more nicotine-containing product than the equivalent of smoking ≤10 cigarettes per day, as judged by the i...
AG-120, also known as ivosidenib, is an investigational small molecule being developed by Agios Pharmaceuticals. It has been studied in Phase 1 clinical trials in healthy volunteers and in subjects with mild or moderate hepatic impairment. The drug is not approved and remains in clinical development.
AG-120 has been studied in Phase 1 clinical trials for use in healthy volunteers and in subjects with mild or moderate hepatic impairment. These trials were designed to investigate the drug's absorption, metabolism, excretion, food effects, and potential drug-drug interactions. AG-120 is not approved for any indication.
AG-120 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AGIO. The company has conducted Phase 1 clinical trials of AG-120 in the United States.
AG-120 is in Phase 1 clinical development. All four clinical trials listed for AG-120 are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities.
AG-120 has been studied in four completed Phase 1 clinical trials: NCT02489513, NCT02579707, NCT02831972, and NCT03282513. These trials enrolled healthy volunteers and subjects with hepatic impairment in the United States, with a total enrollment of 99 participants across all studies.
Yes, AG-120 is also known as ivosidenib. The drug is referred to by both names in clinical research. Agios Pharmaceuticals has studied AG-120, or ivosidenib, in Phase 1 trials involving healthy subjects and those with hepatic impairment.