Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Celerion
Tempe, Arizona, United States
Assess the effect of food on a single-dose PK of pracinostat in nonsmoking healthy adult subjects
Assess the ratios of least square means of pracinostat plasma PK parameters AUC 0-t, AUC 0-inf and Cmax for pracinostat under fed versus fasted conditions
Time frame: 3 days
Evaluate the safety and tolerability of a single-dose of pracinostat under fasted and fed conditions in healthy nonsmoking and smoking adult subjects
All types of adverse events, physical exams, vital signs, 12-lead ECGs, and laboratory safety tests will be performed
Time frame: 1 month
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