drugset / Trial / NCT02088398

Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects

NCT02088398

Phase 1 Completed 19 enrolled Acetylon Pharmaceuticals Incorporated
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

EvaluationDrugModalityDoseRoute
Subject Ricolinostat Small molecule 120 mg Oral
Subject Ricolinostat Small molecule 160 mg Oral

Indications

No indication recorded.