Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00859053
First received: March 6, 2009
Last updated: January 24, 2011
Last verified: November 2009
  Purpose

The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.


Condition Intervention Phase
Hepatic Insufficiency
Drug: BMS-790052
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Single-Dose Pharmacokinetics of BMS-790052 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetic parameters including Cmax, AUC (0-T), and AUC (INF) [ Time Frame: Within 72 or 96 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability. The following assessments will be used to determine this: medical review of adverse event reports and results of physical examination, vital signs, ECGs, and clinical laboratory tests [ Time Frame: Within 72 or 96 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS-790052 in Child-Pugh A Drug: BMS-790052
Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Child-Pugh B Drug: BMS-790052
Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Child-Pugh C Drug: BMS-790052
Capsules, Oral, 30 mg, single dose, one day
Active Comparator: BMS-790052 in Healthy Subjects Drug: BMS-790052
Capsules, Oral, 30 mg, single dose, one day

  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 years, with hepatic impairment conforming to Child-Pugh class A, B or C
  • Each matched control subject determined to be healthy

Exclusion Criteria:

  • History of esophageal and gastric variceal bleeding within past 6 months
  • Primarily cholestatic liver diseases
  • Active alcoholic hepatitis
  • Stable encephalopathy of >= Stage 2
  • Presence of severe ascites or edema
  • Presence of hepatopulmonary or hepatorenal syndrome
  • Positive for HCV, unless HCV RNA is undetectable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859053

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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00859053     History of Changes
Other Study ID Numbers: AI444-013
Study First Received: March 6, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014