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NCT05552183 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by CTI BioPharma.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT05552183: Completed Phase 1 study, sponsored by CTI BioPharma.

NCT05552183 is a Phase 1 study that has completed, run by CTI BioPharma. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05552183, a Phase 1 study, has completed, sponsored by CTI BioPharma.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

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.

Primary Outcome

To characterize and compare the steady-state PK profile of multiple doses (14 days) of 200 mg BID pacritinib in subjects with moderate and severe hepatic impairment with that of healthy matched control subjects with normal liver function.

Interventions

  • DRUG oral dose of 200 mg pacritinib twice daily (BID)

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2022-12-12
Est. Completion 2024-06-10
Phase Phase 1
CTI BioPharma

28 total trials

What the finished NCT05552183 record still lists

NCT05552183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which oral dose of 200 mg pacritinib twice daily (BID) is the first listed.

NCT05552183 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05552183 about?

NCT05552183 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and PK of Pacritinib". 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 ...

What is the current status of trial NCT05552183?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2022-12-12. Estimated completion is 2024-06-10.

What interventions are being tested in trial NCT05552183?

The interventions under investigation include: oral dose of 200 mg pacritinib twice daily (BID) (DRUG).

Who is sponsoring clinical trial NCT05552183?

This trial is sponsored by CTI BioPharma, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05552183's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05552183, the US trial registry maintained by the National Library of Medicine. NCT05552183 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.