This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Celerion
Tempe, Arizona, United States
Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat
Plasma PK parameter Cmax to describe bioavailability of pracinostat
Time frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
Number of participants with Adverse Events as a measure of safety and tolerability of single-dose pracinostat when administered with itraconazole or with ciprofloxacin in healthy nonsmoking adult subjects.
Safety will be monitored through physical examinations, vital sign measurements, electrocardiograms, adverse events, and clinical laboratory tests.
Time frame: 1 month
Peak plasma PK concentration Area Under the Curve (AUC)AUC 0-t, AUC 0-inf in healthy nonsmoking subjects given a single dose of pracinostat
Plasma PK parameter AUC 0-t, AUC 0-inf for pracinostat
Time frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
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