Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032

Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects

The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Drug: BMS-650032

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Res Inst
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C
• Each matched control subjects determined to be healthy

Exclusion Criteria:

• History of esophageal and gastric bleeding within the past 6 months
• Primarily cholestatic liver disease
• Active alcoholic hepatitis
• Stable encephalopathy of ≥Stage 2
• Presence of severe ascites or edema
• Presence of hepatopulmonary or hepatorenal syndrome
• Positive for HIV
• Positive for HCV, unless HCV RNA is undetectable

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMS-650032 in Child-Pugh A	Drug: BMS-650032; Capsules, Oral, 200 mg, BID, 7 Days
Active Comparator: BMS-650032 in Child-Pugh B	Drug: BMS-650032; Capsules, Oral, 200 mg, BID, 7 Days
Active Comparator: BMS-650032 in Child-Pugh C	Drug: BMS-650032; Capsules, Oral, 200 mg, BID, 7 Days
Active Comparator: BMS-650032 in Healthy Subjects	Drug: BMS-650032; Capsules, Oral, 200 mg, BID, 7 Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI	Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs	Day 10
Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples.	Day 10

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Eley T, He B, Chang I, Colston E, Child M, Bedford W, Kandoussi H, Pasquinelli C, Marbury TC, Bertz RJ. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2015;20(1):29-37. doi: 10.3851/IMP2773. Epub 2014 Apr 7.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): October 26, 2011
• Last Update Submitted That Met QC Criteria: October 25, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Asunaprevir
• Other Study ID Numbers: AI447-012