drugset / Trial / NCT02088398
Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
RandomizedCrossoverOpen-labelBasic science
Summary
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. * Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state * Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state * Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state
Timeline
- Start
- 2014-03
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ricolinostat | Small molecule | 120 mg | Oral |
| Subject | Ricolinostat | Small molecule | 160 mg | Oral |
Indications
No indication recorded.