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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
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01019070     History of Changes
Other Study ID Numbers: AI447-012
First Submitted: November 24, 2009
First Posted: November 25, 2009
Last Update Posted: October 26, 2011
Last Verified: October 2011

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