The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Over 96 hours post-dose
Maximum Plasma Concentration (Cmax) of SSP-004184
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Over 96 hours post-dose
Time of Maximum Plasma Concentration (Tmax) for SSP-004184
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Time frame: Over 96 hours post-dose
Plasma Half-Life (T 1/2) of SSP-004184
The time it takes for the blood plasma concentration of a substance to halve.
Time frame: Over 96 hours post-dose
Total Body Clearance (CL/F) of SSP-004184
The rate at which a drug is removed from the body.
Time frame: Over 96 hours post-dose
Volume of Distribution (Vz/F) of SSP-004184
The distribution of a medication between plasma and the rest of the body.
Time frame: Over 96 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.