NCT02807077

PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Pacritinib	Group 1, 2, 3, and 5 will be administered single oral 400-mg dose of pacritinib. Subjects in the Group 4 received a single 400-mg dose of pacritinib during two different treatment periods: Dialysis and Inter-Dialysis

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2016-06-21
• Last updated: 2018-10-22

Locations

3 sites across 3 countries: Germany, Moldova, Romania