A Phase 1 interventional study of Asunaprevir in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by Bristol-Myers Squibb · Phase 1 and Interventional
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
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 48 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Drug: Asunaprevir
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Drug: Asunaprevir
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Drug: Asunaprevir
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Drug: Asunaprevir
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Drug: Asunaprevir
Also known as: BMS-650032
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)
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
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb