The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects. The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
A single oral dose of 448 mg
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Plasma concentrations
Time frame: 8 days
Area under the plasma concentration time curve (AUC)
Time frame: 8 days
Maximum observed plasma concentration (Cmax)
Time frame: 8 days
Time to reach the maximum observed plasma concentration (tmax)
Time frame: 8 days
Apparent terminal elimination rate constant
Time frame: 8 days
Apparent terminal elimination half-life (t½)
Time frame: 8 days
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
Time frame: 8 days
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
Time frame: 8 days
Metabolite to parent ratio (MPR)
Time frame: 8 days
Number of participants with treatment-related adverse events
Time frame: 8days
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