The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Primary Purpose: Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
48
Orlando Clinical Research Center
Orlando, Florida, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States
AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
Area under the concentration-time curve in one dosing interval \[AUC(TAU)\] will be calculated from the blood drug concentration versus time curve
Time frame: 11 time points on Day 7
Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose
Time frame: 1 and 3 hours of Day 7
Maximum observed plasma concentration (Cmax) of Asunaprevir
Pharmacokinetic (PK) parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Time of maximum observed plasma concentration (Tmax) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 11 (blood) and 2 (urine) time points on Day 7
Terminal elimination half life (T-Half) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Percent urinary recovery (%UR) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 3 time points up to Day 7 (urine)
Apparent total body clearance (CLT/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Unbound apparent clearance (CLU/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Renal clearance (CLR) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Apparent volume of distribution (Vd/F) of Asunaprevir
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1
PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time frame: 22 (blood) and 3 (urine) time points on Days 1 and 7
Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results
All recorded adverse events (AEs) will be listed and tabulated by system organ class, preferred term and renal function group. Vital signs and clinical laboratory test results will be listed and summarized by renal function group and time. Any significant physical examination findings and clinical laboratory results will be listed. Electrocardiogram (ECG) readings will be evaluated by the investigator and abnormalities, if present, will be listed
Time frame: Up to Day 15 and until 30 days post discontinuation of dosing