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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
It is statin medicine used to lower cholesterol and triglycerides in the blood.
It lowers bad cholesterol in the blood, and raises good cholesterol
Jasper Clinical Research & Development, Inc.
Kalamazoo, Michigan, United States
Maximum Plasma Concentration [Cmax]
Time frame: 14 days
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