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This study will be an open-label, randomized, single dose, 3-period crossover PK study. This study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1, subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will be administered Treatment A, B, or C according to the randomization schedule.
Subjects will be confined to the Clinical Research Unit (CRU) from the time of Check-in (Day -1) to Day 10. Predose blood and urine samples will be obtained prior to each ACY-1215 administration. Following administration of ACY-1215 in each period, blood and urine samples will be collected at specified timepoints or intervals through 24 hours postdose for the determination of the PK of a single oral dose of ACY-1215. Subjects will be discharged from the CRU on Day 10, following the completion of the last PK collection and successful completion and evaluation of discharge safety tests. Subjects will return to the clinic for a Follow-up visit 5 to 7 days after the last dose of ACY-1215 (Days 14 to 16) for additional safety evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 160 mg ACY-1215 CLF (20 mg/mL) fed | Experimental | • Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state |
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| 120 mg ACY-1215 ALF (10 mg/mL) fed | Experimental | • Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state |
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| 120 mg ACY-1215 ALF (10 mg/mL) fasted | Experimental | • Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACY-1215 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Zero to Last Time - AUC0-last | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters | Changes from baseline in clinical laboratory assessments, vital signs, electrocardiogram values, and physical exam. This includes collection of adverse events and the collection of concomitant medications. | Day 1 (first dose of ACY-1215) to Day 16 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Siebers, M.D. | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Incorporated | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C572255 | ricolinostat |
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| 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose |
| Maximum Observed Plasma Concentration (Cmax) | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose |
| Plasma Decay Half-Life | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose |