We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019070
First Posted: November 25, 2009
Last Update Posted: October 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
November 24, 2009
November 25, 2009
October 26, 2011
December 2009
August 2011   (Final data collection date for primary outcome measure)
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI [ Time Frame: Day 10 ]
Same as current
Complete list of historical versions of study NCT01019070 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 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. [ Time Frame: Day 10 ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Hepatic Insufficiency
Drug: BMS-650032
Capsules, Oral, 200 mg, BID, 7 Days
  • Active Comparator: BMS-650032 in Child-Pugh A
    Intervention: Drug: BMS-650032
  • Active Comparator: BMS-650032 in Child-Pugh B
    Intervention: Drug: BMS-650032
  • Active Comparator: BMS-650032 in Child-Pugh C
    Intervention: Drug: BMS-650032
  • Active Comparator: BMS-650032 in Healthy Subjects
    Intervention: Drug: BMS-650032
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01019070
AI447-012
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP