Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

Hepatitis C Clinical Trial

Official title:

Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886599
• Other study ID #: AI447-033
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2013
• Last updated: November 8, 2013
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Asunaprevir

Locations

Country	Name	City	State
United States	New Orleans Center For Clinical Research	Knoxville	Tennessee
United States	Davita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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)	30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	Yes