Healthy Subjects Clinical Trial
Official title:
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period, 2-Treatment-Sequence Crossover Study to Assess the Relative Bioavailability of Pacritinib Following Oral Administration as Capsule and Solution Formulations in Healthy Subjects
This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the relative bioavailability of pacritinib following administration as a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK and major human metabolites of pacritinib.
Twelve healthy subjects will be enrolled in the study (6 subjects per sequence) at a single clinical site with the intent that 12 subjects complete Periods 1 and 2 in the study. Subjects will be randomly assigned to 2 possible sequences (6 subjects per sequence) on Day 1 of Period 1. Subjects will be randomly assigned to 2 possible sequences. Each subject received 2 treatments (a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg oral solution dose of pacritinib) in a 2-period crossover design. Each treatment will be administered as monotherapy during 1 of 2 treatment periods with a 7-day washout period between administrations of each study medication. ;
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