A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males

This is an exploratory study in a small, well controlled group of healthy subjects to
explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and
ezetimibe).

The overall design of the trial is to administer drugs that are metabolized through these
transporters to quantify the impact CXA-10 may have on the exposure of these drugs.

The study will also examine the 24-h urine total creatinine excretion prior to and following
administration of CXA-10 to examine the effects of CXA-10, if any, either directly on
creatinine transporters or through enhanced creatinine production.

To reduce the potential variability in drug exposure levels, the study population will only
include male subjects between 19 to 25 years of age.

Inclusion Criteria:

- In good general health as determined by a thorough medical history and physical
examination, ECG, vital signs, and clinical laboratory evaluation. Results of
clinical laboratory tests must be without clinically significant abnormalities for
this population and may exceed the limits of the reference ranges, including
hematology, clinical chemistry and urinalysis except as noted below.

- Resting HR greater than or equal to 45 beats per minute (BPM) after 5 minute rest at
screening.

- QTcF interval must be less than or equal to 430msec at screening and pre-dose.

Exclusion Criteria:

- Any clinically relevant abnormality for this population identified on the screening
history, physical or laboratory examinations, or any other medical condition or
circumstance making the volunteer unsuitable for participation in the study.

- Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations,
personal or family history of congenital prolonged QT syndromes or sudden unexpected
death due to a cardiac reason.

- Treatment with any prescription or non-prescription drugs (including vitamins, herbal
and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to
dosing and until collection of the final PK sample.

- History of smoking, including e-cigarettes, or use of nicotine-containing products
within 1 month of screening.

- Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR
interval, QRS deviation) or any clinically significant ECG abnormality will be
excluded from the study.