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This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design. PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG120 | Drug | AG120 in fed and fasted conditions. Part 2- AG120 single dose exposure |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration of AG-120 | Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose. |
| Incidence of adverse events | Assessment of adverse events | 22 days |
| Tmax | Time of maximum concentration of AG-120 | Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose. |
| AUC0-t | Area under the concentration-time curve from Hour 0 to the last measurable concentration | Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose. |
| AUC0-infinity | Area under the concentration-time curve extrapolated to infinity | Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose. |
| t1/2 | Apparent terminal elimination half-life | Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Agresta, MD | Agios Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000627630 | ivosidenib |
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