Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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