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
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: 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 August 28, 2014