Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects

Sponsor
CTI BioPharma
Study ID
NCT02765724
Phase
PHASE1
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Pacritinib — DRUG
    Pacritinib 400 mg (4 capsules of 100 mg each), single dose, oral administration

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
May 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1
    Patients with mild hepatic impairment
  • Experimental: Group 2
    Patients with moderate hepatic impairment
  • Experimental: Group 3
    Patients with severe hepatic impairment
  • Experimental: Group 4
    Healthy subjects

Primary Outcome Measure

To characterize the pharmacokinetic profile of a single 400-mg dose of pacritinib and its major metabolites in patients with hepatic impairment as compared to gender-, age-, and body mass index -matched healthy subjects with normal liver function [ Time Frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose ]

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