This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Single 4.5 μg/kg dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Time frame: From hour 0 (pre-dose) to 288 hours post-dose
AUC From Time 0 to the Last Measurable Sample (AUC0-last)
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Maximum Observed Serum Concentration (Cmax)
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Time frame: From hour 0 (pre-dose) to 288 hours post-dose
Time to Maximum Observed Serum Concentration (Tmax)
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Terminal Half-life (T1/2)
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Total Body Clearance (CL/F)
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Volume of Distribution (Vd/F)
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
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Time frame: From hour 0 (pre-dose) up to 288 hours post-dose