Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
- Registration Number
- NCT01886599
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Group A: Subjects with normal renal function
- Group B: Patients with end stage renal disease
- Group C: Patients with mild renal impairment
- Group D: Patients with moderate renal impairment
- Group E: Patients with severe renal impairment
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
- Hepatitis B or C
- Human Immunodeficiency Virus (HIV)
- Recent gastrointestinal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Subjects with normal renal function Asunaprevir Asunaprevir 100 mg tablet by mouth twice daily for 7 days Arm B: Subjects with end stage renal disease Asunaprevir Asunaprevir 100 mg tablet by mouth twice daily for 7 days Arm C: Subjects with mild renal impairment Asunaprevir Asunaprevir 100 mg tablet by mouth twice daily for 7 days Arm D: Subjects with moderate renal impairment Asunaprevir Asunaprevir 100 mg tablet by mouth twice daily for 7 days Arm E: Subjects with severe renal impairment Asunaprevir Asunaprevir 100 mg tablet by mouth twice daily for 7 days
- Primary Outcome Measures
Name Time Method AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7 11 time points 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
- Secondary Outcome Measures
Name Time Method Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose 1 and 3 hours of Day 7 Maximum observed plasma concentration (Cmax) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) Pharmacokinetic (PK) parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Time of maximum observed plasma concentration (Tmax) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir 11 (blood) and 2 (urine) time points on Day 7 PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Terminal elimination half life (T-Half) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Percent urinary recovery (%UR) of Asunaprevir 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Apparent total body clearance (CLT/F) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Unbound apparent clearance (CLU/F) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Renal clearance (CLR) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Apparent volume of distribution (Vd/F) of Asunaprevir 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1 22 (blood) and 3 (urine) time points on Days 1 and 7 PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results Up to Day 15 and until 30 days post discontinuation of dosing 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
Trial Locations
- Locations (3)
Davita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
New Orleans Center For Clinical Research
🇺🇸Knoxville, Tennessee, United States