Skip to main content
OpenTrials
Completed

NCT Number: NCT01886599

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center, Orlando, Florida, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asunaprevir

Drug

Other names: BMS-650032

Primary outcomes

  1. AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7

    Time frame: 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 outcomes

  1. 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

  2. Maximum observed plasma concentration (Cmax) of Asunaprevir

    Time frame: 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)

  3. Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir

    Time frame: 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)

  4. Time of maximum observed plasma concentration (Tmax) of Asunaprevir

    Time frame: 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)

  5. Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir

    Time frame: 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)

  6. Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir

    Time frame: 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)

  7. Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir

    Time frame: 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)

  8. Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir

    Time frame: 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)

  9. Terminal elimination half life (T-Half) of Asunaprevir

    Time frame: 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)

  10. Percent urinary recovery (%UR) of Asunaprevir

    Time frame: 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)

  11. Apparent total body clearance (CLT/F) of Asunaprevir

    Time frame: 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)

  12. Unbound apparent clearance (CLU/F) of Asunaprevir

    Time frame: 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)

  13. Renal clearance (CLR) of Asunaprevir

    Time frame: 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)

  14. Apparent volume of distribution (Vd/F) of Asunaprevir

    Time frame: 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)

  15. Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1

    Time frame: 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)

  16. Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.