Hepatic ImpairmentPhase 1NCT05552183

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

A Phase 1 study testing oral dose of 200 mg pacritinib twice daily (BID) in people with Hepatic Impairment, run by CTI BioPharma at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment
What is being tested?: oral dose of 200 mg pacritinib twice daily (BID)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: 12 Dec 2022to 10 Jun 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to provide written informed consent.
Able to communicate well with the investigator and understands and agrees to comply with all protocol requirements.
Is male or female ≥18 to ≤85 years of age, inclusive, at screening.
Has a BMI 18.0 to 42.0 kg/m2, inclusive, at screening.
Female subjects of childbearing potential must be surgically sterile, or postmenopausal, or agree use an acceptable method of birth control from the time of ICF or 10 days prior to check-in and until 30 days after Day 21. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in.
Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or to practice abstinence during the study from check-in until 90 days following Day 21.

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Male subjects must refrain from sperm donation from check-in until 90 days following Day 21.
Additional Inclusion Criteria for Subjects with Hepatic Impairment Only:
Has chronic (>6 months) and stable hepatic impairment (ie, no acute episodes of illness within 30 days prior to screening due to deterioration of hepatic function) as assessed by a Child-Pugh classification score of moderate (7 to 9 points) or severe (10 to 15 points).
Is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead ECG results, and physical examination findings, except for findings that, as judged by the investigator, are consistent with the subject's hepatic impairment or other stable concomitant medical conditions at screening and check-in.
Additional Inclusion Criteria for Healthy Subjects Only:
Has normal hepatic function.
Must match a subject in Group 1 and/or Group 2, with respect to sex, age (±10 years), and BMI (±20%).
Is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead ECG results, and physical examination findings at screening and check-in.

Who cannot join

Has a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
Has any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subjects participation in the study. The investigator should be guided by evidence of any of the following:
History of inflammatory bowel disease
History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (esophageal varix surgery is allowable)
Clinical evidence of pancreatic injury or pancreatitis
Evidence of urinary obstruction or difficulty in voiding at screening

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Has a baseline seated systolic blood pressure >160 mm Hg or ≤90 mm Hg and a diastolic blood pressure of >100 mm Hg or ≤50 mm Hg, inclusive, at screening and check in unless deemed not clinically significant by the investigator, as approved by the sponsor.
Has a baseline seated pulse rate of <50 bpm or >100 bpm and/or an oral body temperature <35.0°C or >37.5°C when vital signs are measured at screening and check in.
Has a significant QT interval prolongation (QTcF of >480 msec) or other risks for QT prolongation at screening or check-in.
Has a history of being immunocompromised or has a positive serum test result for HIV types 1 or 2 antibodies at screening.
Has had a significant illness within the 2 weeks prior to check-in.
Has a history of alcoholism, drug abuse, or alcohol withdrawal within 3 months before screening, or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
Is unable or unwilling to abstain from alcohol from 72 hours prior to check-in until Day 21.
Is unable or unwilling to abstain from caffeine, xanthine-containing beverages or food (eg, coffee, tea, chocolate, and caffeinated sodas, colas) from check in until Day 21.
Has consumed grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 7 days prior to check-in to the study site until Day 21.
Smokes >10 cigarettes daily and is unwilling to reduce to ≤5 daily from the time of screening through Day 21.
Is involved in strenuous activity or contact sports within 24 hours prior to check-in or during the study.
Has donated blood or blood products >450 mL within 30 days prior to the first dose of study drug.
Has used over-the-counter medications (except as prescribed by a physician or paracetamol [up to 2 g per day]), vitamins, or phyto-therapeutic/herbal/plant-derived preparations within 14 days of check-in.
Has used a potent CYP3A4 inducer within 30 days prior to check-in or used a potent CYP3A4 inhibitor within 15 days prior to check-in.
Has received treatment in another clinical study of an investigational drug (or medical device) or investigational vaccine within 30 days or 5 half-lives (whichever is longer) prior to check-in.
The subject has previously received pacritinib.
Has a known hypersensitivity to study drug (ie, allergy to pacritinib or any excipients or drugs similar to pacritinib).
Has had a recent bleeding event of Grade ≥2 within 3 months prior to first dose of study drug.
Has used antiplatelet or anticoagulant therapy within 14 days prior to check in with the exception of aspirin at doses ≤100 mg daily.
Has a history of heart failure with a New York Heart Association Class II or above.
Has a recent cardiac event of Grade ≥3 within 6 months prior to check in.
In the opinion of the investigator, the subject is not suitable for entry into the study.
Additional Exclusion Criteria for Subjects with Hepatic Impairment Only:
Has fluctuating or rapidly deteriorating hepatic function, as indicated by recent history or worsening of clinical (ie, abdominal pain, nausea, vomiting, anorexia, or fever) and/or laboratory signs of hepatic impairment, as judged by the investigator.
Has symptoms or history of Stage II or worse degree of encephalopathy that would prohibit informed consent within 6 months before check-in, as judged by the investigator.
Has clinical evidence of ascites that requires paracentesis more frequently than every 3 weeks at screening or check-in.
Has a history of a surgical portosystemic shunt.
Has evidence of hepatorenal syndrome.
Has any of the following laboratory results:
Estimated serum creatinine clearance (Cockcroft-Gault) <50 mL/min
Absolute neutrophil count <1500 cells/mm3
Platelet count <30,000 cells/mm3
Hemoglobin <9 g/dL
Activated partial thromboplastin time, international normalized ratio, partial thromboplastin time, or prothrombin time clinically significant per investigator discretion.
Has evidence of progressive liver disease (as available within the last 4 weeks, including the time period between screening and check-in) as indicated by liver transaminases, alkaline phosphatase, and gamma-glutamyl transpeptidase, as judged by the investigator.
Has evidence of active acute or chronic hepatitis B virus.
Has a positive test result for drugs of abuse (except for positive results associated with prescription medications that have been reviewed and approved by the investigator) or positive alcohol urine or breath test at screening or check-in. A positive tetrahydrocannabinol result at screening will not be exclusionary, but must be negative at check-in.
Has a urinalysis with any result outside the normal range and deemed clinically significant by the investigator. Results deemed not clinically significant by the investigator in consultation with the sponsor may be allowed.
Has initiated any otherwise allowable prescription or over-the-counter medications within 15 days of check-in. Some of these medications may have to be discontinued 12 to 48 hours before study drug dosing, or earlier. As medication regimens vary and cannot be predicted, each subject will be discussed with the sponsor individually. The dose of an approved medication must remain stable from 7 days before study drug dosing and throughout the study.
Additional Exclusion Criteria for Healthy Subjects Only:
Has a positive test result for hepatitis B surface antigen and/or hepatitis C virus antibodies.
Any screening or check-in laboratory results outside the normal range and deemed clinically significant. Results outside the normal range and deemed not clinically significant by investigator, in consultation with the sponsor, are allowable.
Has used any prescription medication within 30 days prior to check in.
Activated partial thromboplastin time, international normalized ratio, partial thromboplastin time, or prothrombin time > 1.5 × ULN.
Has a positive test result for drugs of abuse or positive alcohol urine or breath test prior to the first dose of study drug.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Site 2
Orlando, Florida, 32809
Site 1
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pacritinib in Subjects With Varying Degrees of Hepatic Impairment Compared to Healthy Subjects

Read the detailed description

This is a Phase 1, multi-center, open-label, multiple-dose, parallel-group study designed to assess the effect of hepatic insufficiency on the PK of 200 mg BID pacritinib. A total of approximately 22 to 32 subjects are planned, with approximately 8 moderate hepatically impaired subjects, approximately 6 to 8 severe hepatically impaired subjects, and approximately 8 to 16 healthy subjects with normal hepatic function. The primary objective of this study is to characterize and compare the steady-state PK profile of multiple doses (14 days) of 200 mg BID pacritinib in the study population, and the secondary objective is to evaluate the safety and tolerability of multiple doses (14 days) of 200 mg BID pacritinib. The study will consist of a screening period (Day -28 to Day -2), check-in (Day -1), a confinement period including treatment period (Day 1 through Day 14) and post-treatment period (Day 15 through Day 20), followed by a discharge visit (Day 21), and an EOS follow-up telephone call (Day 44). Serial blood samples for PK analysis of pacritinib will be collected pre dose through Day 21 at protocol-specified timepoints CK 18 will be collected . Safety and tolerability will be assessed by AEs, clinical laboratory tests, vital will occur 4 and 24 hours after the AM dose on Day 1, Day 10, Day 12, and Day 14 signs, ECGs, and physical examinations.

Conditions: Hepatic Impairment
Being tested: oral dose of 200 mg pacritinib twice daily (BID)
Keywords: Pacritinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral dose of 200 mg pacritinib twice daily (BID)Drug
Subjects will receive 200 mg BID pacritinib for 14 days.

Study groups in NCT05552183
Study group	Role	What they receive
Moderate Hepatic Impairment	Experimental	Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7-9 will receive 14 days of 200 mg BID pacritinib. Receives: Drug: oral dose of 200 mg pacritinib twice daily (BID)
Severe Hepatic Impairment	Experimental	Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10-15 will receive 14 days of 200 mg BID pacritinib. Receives: Drug: oral dose of 200 mg pacritinib twice daily (BID)
Normal Hepatic Function	Experimental	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. Receives: Drug: oral dose of 200 mg pacritinib twice daily (BID)

What is being measured

The primary outcome is the main question the study is designed to answer.

PK
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.
Measured: Day 1- (Day 1: Cmax)
PK
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.
Measured: Day 1(Day 1: Tmax)
PK
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.
Measured: Day 1( AUC0-12)
PK
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.
Measured: Day 14: Cmax,
PK
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.
Measured: Day 14: Tmax,
PK
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.
Measured: Day 14 t1/2
PK
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.
Measured: Day 14 CL/F
PK
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.
Measured: Day 14 AUC0 t
PK
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.
Measured: Day 14 AUC0 -12
PK
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.
Measured: Day 14 λZ,
PK
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.
Measured: Day 14 Vz/F
PK
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.
Measured: Day 14 f/u
PK
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.
Measured: Day 14 ARCmax
PK
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.
Measured: Day 14 ARAUC0-12

Secondary outcomes (5)

Incidence of adverse events
Safety and tolerability of pacritinib, including monitoring of adverse events (AEs); an AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage
Measured: Day 1-44
Incidence of clinical laboratory abnormalities
Safety and tolerability of pacritinib, including hematology, coagulation, chemistry, and urinalysis parameters
Measured: Day 1-21
Incidence of vital sign abnormalities
Safety and tolerability of pacritinib, including monitoring of blood pressure, heart rate, respiratory rate, and body temperature
Measured: Day 1-21
Incidence of ECG abnormalities
Safety and tolerability of pacritinib, including monitoring of RR interval, PR interval, QRS width, QT interval, and QTcF
Measured: Day1-21
Incidence of physical examination abnormalities
Safety and tolerability of pacritinib, including monitoring for abnormalities on physical examination
Measured: Day 1-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 202210 Jun 2024

First posted23 Sep 2022
Study start12 Dec 2022
Primary completion10 Jun 2024
Study completion10 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05552183
Sponsor's protocol ID: PAC110
Status last verified: Oct 2024
First submitted: 13 Sep 2022
Last updated: 21 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pacritinib in Subjects With Varying Degrees of Hepatic Impairment Compared to Healthy Subjects
ClinicalTrials.gov ID: NCT05552183
Acronym / sponsor ID: PAC110
Conditions: Hepatic Impairment
Keywords: Pacritinib
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: CTI BioPharmaIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 12 Dec 2022 (actual)
Primary completion: 10 Jun 2024 (actual)
Study completion: 10 Jun 2024 (actual)
First posted: 23 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Moderate Hepatic Impairment	Experimental	Drug: oral dose of 200 mg pacritinib twice daily (BID)Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7-9 will receive 14 days of 200 mg BID pacritinib.
Severe Hepatic Impairment	Experimental	Drug: oral dose of 200 mg pacritinib twice daily (BID)Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10-15 will receive 14 days of 200 mg BID pacritinib.
Normal Hepatic Function	Experimental	Drug: oral dose of 200 mg pacritinib twice daily (BID)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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Able to provide written informed consent.
Able to communicate well with the investigator and understands and agrees to comply with all protocol requirements.
Is male or female ≥18 to ≤85 years of age, inclusive, at screening.
Has a BMI 18.0 to 42.0 kg/m2, inclusive, at screening.
Female subjects of childbearing potential must be surgically sterile, or postmenopausal, or agree use an acceptable method of birth control from the time of ICF or 10 days prior to check-in and until 30 days after Day 21. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in.

Key exclusion criteria (51 listed)

Has a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
Has any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subjects participation in the study. The investigator should be guided by evidence of any of the following:
Has a baseline seated systolic blood pressure >160 mm Hg or ≤90 mm Hg and a diastolic blood pressure of >100 mm Hg or ≤50 mm Hg, inclusive, at screening and check in unless deemed not clinically significant by the investigator, as approved by the sponsor.
Has a baseline seated pulse rate of <50 bpm or >100 bpm and/or an oral body temperature <35.0°C or >37.5°C when vital signs are measured at screening and check in.
Has a significant QT interval prolongation (QTcF of >480 msec) or other risks for QT prolongation at screening or check-in.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral dose of 200 mg pacritinib twice daily (BID)Subjects will receive 200 mg BID pacritinib for 14 days.	Drug	Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment

Primary outcome

PK
Time frame: Day 1- (Day 1: Cmax)
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.
PK
Time frame: Day 1(Day 1: Tmax)
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.
PK
Time frame: Day 1( AUC0-12)
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.
PK
Time frame: Day 14: Cmax,
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.
PK
Time frame: Day 14: Tmax,
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.
PK
Time frame: Day 14 t1/2
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.
PK
Time frame: Day 14 CL/F
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.
PK
Time frame: Day 14 AUC0 t
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.
PK
Time frame: Day 14 AUC0 -12
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.
PK
Time frame: Day 14 λZ,
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.
PK
Time frame: Day 14 Vz/F
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.
PK
Time frame: Day 14 f/u
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.
PK
Time frame: Day 14 ARCmax
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.
PK
Time frame: Day 14 ARAUC0-12
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.

5 secondary outcomes

Incidence of adverse events
Time frame: Day 1-44
Incidence of clinical laboratory abnormalities
Time frame: Day 1-21
Incidence of vital sign abnormalities
Time frame: Day 1-21
Incidence of ECG abnormalities
Time frame: Day1-21
Incidence of physical examination abnormalities
Time frame: Day 1-21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Buckley study director

Sobi, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oral dose of 200 mg pacritinib twice daily (BID) in people with Hepatic Impairment, run by CTI BioPharma at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK (time frame: Day 1- (Day 1: Cmax)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.