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The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG-881 | Experimental | Participants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG881 | Drug | AG-881 tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Apparent Clearance Following Extravascular Dosing (CL/F) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Maximum Plasma Concentration Observed (Cmax) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Apparent Terminal Elimination Half-life (t1/2) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Time of Maximum Plasma Concentration (tmax) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 | |
| Apparent Volume of Distribution (Vd/F) of AG881 | Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2 | Clinical laboratory assessments will include hematology, blood chemistry, and urinalysis. | Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days) |
| Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Agios Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT GLobal | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42053456 | Derived | Limsakun T, Man A, Nguyen D, Hossain M. A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants. J Clin Pharmacol. 2026 May;66(5):e70196. doi: 10.1002/jcph.70196. |
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| ID | Term |
|---|---|
| C000716758 | vorasidenib |
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Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems. |
| Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days) |
| Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2 | Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate. | Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days) |
| Number of Participants with Changes in Electrocardiograms (ECGs) from Screening to 22 days in Period 1 and 2 | Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days) |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related. | Up to 28 days after last dose of AG-881 (Up to 71 days) |
| Number of Participants Using Concomitant Medications | Up to 28 days after last dose of AG-881 (Up to 71 days) |