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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 16, 2014