PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
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.