A phase 1, open-label study to investigate the absorption, metabolism, excretion, and mass balance of [14C]pacritinib following a single oral dose in healthy male subjects.

To investigate the absorption, metabolism, excretion as well as
safety/tolerability of pacritinib after a single oral dose.

To characterize the clearance pathways, the routes of excretion, total recovery
of radioactivity, pacritinib and its major metabolites in healthy subjects
following administration of a single oral dose of 400 mg [14C]pacritinib

To characterize the pharmacokinetics (PK) of total radioactivity, pacritinib
and its major metabolites following administration of a single oral dose of 400
mg [14C]pacritinib in healthy subjects.
To assess the safety and tolerability of a single oral dose of 400 mg
[14C]pacritinib in healthy subjects.

This is a phase 1, open-label study to investigate the absorption, metabolism,
excretion, and mass balance of [14C]pacritinib following a single oral dose in
healthy male subjects.

The study will start with a screening visit. During the screening visit
standard medical assessments including safety laboratory tests (blood draw,
urine collection), an alcohol breath test, urine drug screen, a physical
examination, ECG and a vital signs measurement will be performed. After the
subject passes all above mentioned tests,the subject will be enrolled in the
study.

During study the subject will enter the clinic. The subjects will receive 1
radiolabeled medication once on day 1. The subject will be asked on a regular
basis for possible side effects, blood, urine, fecal samples will be collected
for PK and the vital signs, ECG will be checked during the confinement period
and possibly required follow-up visits.On a daily basis blood and urine samples
will be taken for safety laboratory tests.

Finally a End of Study examination will be performed. During this visit the
subjects will be asked for possible side effects, blood and urine will be
collected for safety, the vital signs and ECG will be checked and a physical
examination will be conducted.

The risk is small. The patients will be closely monitored. The patients will be
regularly questioned for any side effects and safety tests are scheduled (vital
signs). The patients will be asked to report, as soon as possible, any changes
in physical and/or mental well being.

The blood collection procedure is not dangerous, but may cause discomfort or
bruising. Occasionally, fainting or an infection at the blood sampling site may
occur.

Shaving may be required for proper placemant of ECG patches. This may cause
irritation or bleeding of the skin. ECG patches may cause redness, itching,
rash, or blisters on the skin and/or hair loss due to removal of ECG patches.