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

NCT05552183 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-10-21

No results posted yet for this study

Summary

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

oral dose of 200 mg pacritinib twice daily (BID)

Subjects will receive 200 mg BID pacritinib for 14 days.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Buckley · Sobi, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-06-10
Completion
2024-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552183 on ClinicalTrials.gov