Clinical trial NCT01886599: Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
Official title: Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
timeFrame: 11 time points on Day 7
Secondary outcomes:
measure: Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose
timeFrame: 1 and 3 hours of Day 7
measure: Maximum observed plasma concentration (Cmax) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Time of maximum observed plasma concentration (Tmax) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir
timeFrame: 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
measure: Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir
timeFrame: 11 (blood) and 2 (urine) time points on Day 7
measure: Terminal elimination half life (T-Half) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Percent urinary recovery (%UR) of Asunaprevir
timeFrame: 3 time points up to Day 7 (urine)
measure: Apparent total body clearance (CLT/F) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Unbound apparent clearance (CLU/F) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Renal clearance (CLR) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Apparent volume of distribution (Vd/F) of Asunaprevir
timeFrame: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
measure: Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1
timeFrame: 22 (blood) and 3 (urine) time points on Days 1 and 7
measure: Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results
timeFrame: Up to Day 15 and until 30 days post discontinuation of dosing
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
city: Knoxville
country: United States
facility: New Orleans Center For Clinical Research
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: