Groups 1, 2, and 3 will consist of 8 patients each with mild, moderate, or severe renal disease, respectively, based on their estimated glomerular filtration rate (eGFR, calculated by the Modification of Diet in Renal Disease [MDRD] study equation). Each of these patients will receive a single 400 mg dose of pacritinib.~Group 4 will consist of 8 patients with ESRD requiring hemodialysis who have been on a stable dialysis regimen for at least 6 months. In this cohort only, patients will participate in 2 treatment periods, Dialysis and Inter-Dialysis, separated by a 14-day period between pacritinib administration. In the Dialysis Treatment Period, a single 400 mg dose of pacritinib will be administered 4 hours prior to each patient's normally scheduled hemodialysis. In the Inter-Dialysis Treatment Period, a single 400 mg dose of pacritinib will be administered immediately after the end of the patient's normally scheduled hemodialysis session.~Group 5 will consist of 8 healthy subjects enrolled to match the sex-, age-, and weight of the patients with mild, moderate, and severe renal impairment and patients with ESRD enrolled in the study. Healthy subjects will be administered a single 400 mg dose of pacritinib.
This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal impairment.