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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Subjects with normal renal function | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
|
| Arm B: Subjects with end stage renal disease | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
|
| Arm C: Subjects with mild renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
|
| Arm D: Subjects with moderate renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
|
| Arm E: Subjects with severe renal impairment | Experimental | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asunaprevir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 11 time points on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pharmacokinetic (PK) parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| Davita Clinical Research |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C571889 | asunaprevir |
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|
| 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) | 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) | 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) | 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine) |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | Up to Day 15 and until 30 days post discontinuation of dosing |
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| New Orleans Center For Clinical Research | Knoxville | Tennessee | 37920 | United States |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |