Study to Evaluate the Safety, Tolerability, and PK of Pacritinib

Part of paid clinical trials in Orlando, Florida.

Sponsor
CTI BioPharma
Study ID
NCT05552183
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a Phase 1 study designed to assess the effect of hepatic insufficiency on the PK of pacritinib by study of 14-day BID dosing of pacritinib in subjects with moderate and severe hepatic impairment compared to healthy matched control subjects with normal liver function. Safety and tolerability of multiple day dosing of pacritinib in the subject populations will also be evaluated.

Key Dates

Start date
Dec 12, 2022
Status verified
Oct 2024
Primary completion
Jun 10, 2024
Completion
Jun 10, 2024

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate Hepatic Impairment
    Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7-9 will receive 14 days of 200 mg BID pacritinib.
  • Experimental: Severe Hepatic Impairment
    Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10-15 will receive 14 days of 200 mg BID pacritinib.
  • Experimental: Normal Hepatic Function
    Healthy subjects who have normal hepatic function with age (± 10 years; ≥ 18 years old and ≤ 85 years old), BMI (±20%), and sex, matching with the moderate and severe hepatic impairment cohorts will receive 14 days of 200 mg BID pacritinib.

Primary Outcome Measure

PK [ Time Frame: Day 1- (Day 1: Cmax) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Site 2OrlandoFlorida32809-
Site 1San AntonioTexas78215-

Find similar trials in Orlando, FL

By research site
Site 2· Orlando, FLSite 1· San Antonio, TX

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