The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Single oral 500 mg dose
Investigator Site 101
Orlando, Florida, United States
Investigator Site 102
Minneapolis, Minnesota, United States
Investigator Site 103
Knoxville, Tennessee, United States
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
Time frame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose
Safety measures to include adverse events and changes in clinical laboratory results
Time frame: From admistration of study drug through follow-up on Day 8
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