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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01019070
First received: November 24, 2009
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatic Insufficiency
 Drug: BMS-650032
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019070

Locations
United States, California
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01019070     History of Changes
Other Study ID Numbers: AI447-012
Study First Received: November 24, 2009
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013