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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01019070
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Arms: 4
• Duration (Months): 20
• Patients Per Site: 14
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency	Drug: BMS-650032	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• 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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI [Day 10]

Secondary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Res Inst	Anaheim	California	United States	92801
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01019070
• Other Study ID Numbers: AI447-012
• First Posted: Nov 25, 2009
• Last Update Posted: Oct 26, 2011
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure; Asunaprevir

Study Results

No Results Posted as of Oct 26, 2011