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

Hepatic Insufficiency Clinical Trial

Official title:

Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019070
• Other study ID #: AI447-012
• Status: Completed
• Phase: Phase 1
• First received: November 24, 2009
• Last updated: October 25, 2011
• Start date: December 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatic Insufficiency

Intervention

Drug:
• BMS-650032
Capsules, Oral, 200 mg, BID, 7 Days

Locations

Country	Name	City	State
United States	Advanced Clinical Res Inst	Anaheim	California
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI		Day 10	No
Secondary	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		Day 10	Yes
Secondary	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.		Day 10	No

External Links

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