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Also known as [14C]-AG-120, AG-120 (Ivosidenib)
AG-120 · 1 trial · 1 indication
AG-120 Cmax, derived from plasma concentration-time curves
AG-120 AUC, derived from plasma concentration-time curves
| 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. |
| Name | Type | Description |
|---|---|---|
| AG-120 (Ivosidenib) | DRUG | Single 500 mg dose of AG-120 (Ivosidenib). |
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 is an investigational small molecule developed by Agios Pharmaceuticals, Inc. (ticker: AGIO). It has been studied in a Phase 1 clinical trial in people with hepatic impairment, a condition in which liver function is reduced. AG-120 is also known as ivosidenib.
AG-120 was evaluated in a Phase 1 study to assess its use in individuals with mild or moderate hepatic impairment compared with those with normal hepatic function. The study has been completed. AG-120 is not approved for any indication and remains investigational.
AG-120 is developed by Agios Pharmaceuticals, Inc., which trades under the ticker symbol AGIO. Agios is a biopharmaceutical company focused on the discovery and development of small molecule medicines.
AG-120 has been tested in a Phase 1 clinical trial. That trial, NCT03282513, has been completed. AG-120 is an investigational drug and has not been approved by the FDA for any use.
AG-120 was studied in one completed Phase 1 trial, NCT03282513, titled "A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function." The trial enrolled 33 participants in the United States and was active-controlled.
Yes, AG-120 is also known as ivosidenib. Other names used for AG-120 include AG120 and [14C]-AG-120. The trial NCT03282513 refers to the drug as AG-120 (Ivosidenib).