Myelofibrosis Clinical Trial
Official title:
A Phase 1 Open-Label, Single-Dose, Parallel-Group Study to Determine the Pharmacokinetics of Pacritinib in Patients With Mild, Moderate, and Severe Renal Impairment and End-Stage Renal Disease (ESRD) Compared to Healthy Subjects
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.
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.
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