Hepatitis C
Conditions
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
Interventions
DRUGAsunaprevir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 | — |
| 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 |
| 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) |
Countries
United States
Outcome results
None listed