The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants with various degrees of impaired renal function (mild \[Cohort 1\], moderate \[Cohort 2\], severe \[Cohort 3\]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Knoxville, Tennessee, United States
Maximum Observed Concentration (Cmax) of AL-335
The Cmax is the maximum observed concentration of analyte (AL-335).
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity)
The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to follow-up (Approximately 30-35 days after study drug administration)
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