Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG120 · 2 trials · 1 indication
Maximum observed concentration of AG-120
Assessment of adverse events
Time of maximum concentration of AG-120
Area under the concentration-time curve from Hour 0 to the last measurable concentration
Area under the concentration-time curve extrapolated to infinity
Apparent terminal elimination half-life
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | A single oral dose of AG-120 will be administered at Hour 0 followed by PK sampling for 504 hours (21 days). |
| Period 2 | EXPERIMENTAL | In Period 2, multiple oral doses of itraconazole will be administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days) following AG-120 dosing on Day 1. PK sampling will also be collected for itraconazole and its metabolite, hydroxy-itraconazole, from Day -2 up to Day 13. |
| Treatment A: Unfed | ACTIVE_COMPARATOR | Treatment A: Single oral dose of AG-120 at Hour 0 on Day 1, following a 10-hour overnight fast. |
| Treatment B: Fed | ACTIVE_COMPARATOR | Treatment B: Single oral dose of AG-120 at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast. |
| Part 2 Single Dose | EXPERIMENTAL | PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120. |
| Name | Type | Description |
|---|---|---|
| AG120 | DRUG | - |
| Itraconazole | DRUG | - |
Inclusion Criteria: 1. Healthy, adult, male or female, 18 - 55 years of age, inclusive, at screening. 2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study. 3. BMI ≥ 18.5 and ≤ 32.0 kg/m2 at screening. 4. Medica...
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.