NCT02765724

Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects

A Phase 1 Open Label, Single Dose, Parallel-Group Study to Determine the Pharmacokinetics of Pacritinib in Patients With Impaired Hepatic Function in Comparison With Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg pacritinib administered orally to patients with stable chronic liver disease and healthy control subjects.

Detailed description

All study participants will undergo screening evaluations to determine eligibility for the study. All screening evaluations must be performed within 28 days of pacritinib dosing (Day 1). Assignment of patients to each hepatic impairment group will be defined by Child-Pugh Clinical Assessment Score at the time of Screening. Group 3 patients will not be dosed until at least 2 patients combined from Groups 1 and 2 have completed the study (Day 8). Healthy subjects will be enrolled after hepatic impairment accrual is complete to allow for age-, gender- and body mass index- (BMI) matching with the hepatic impairment population. Participants will be admitted to the study site on Day -1 (i.e., Check-in). On Day 1, upon receipt of all baseline safety evaluation results and confirmation of eligibility, study participants will be administered a single dose of 400 mg pacritinib orally under fasting conditions. Fasting will start 10 hours prior to pacritinib administration and continue for an additional 4 hours after administration. Following administration of pacritinib, participants will remain confined to the study site for 168 hours (8 days) after pacritinib dosing for collection of blood for PK and safety assessments.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Pacritinib	Pacritinib 400 mg (4 capsules of 100 mg each), single dose, oral administration

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2016-05-09
• Last updated: 2020-03-06

Locations

2 sites across 2 countries: Germany, Moldova