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

NCT ID: NCT01019070

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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BMS-650032 in Child-Pugh A

Group Type ACTIVE_COMPARATOR

BMS-650032

Intervention Type DRUG

Capsules, Oral, 200 mg, BID, 7 Days

BMS-650032 in Child-Pugh B

Group Type ACTIVE_COMPARATOR

BMS-650032

Intervention Type DRUG

Capsules, Oral, 200 mg, BID, 7 Days

BMS-650032 in Child-Pugh C

Group Type ACTIVE_COMPARATOR

BMS-650032

Intervention Type DRUG

Capsules, Oral, 200 mg, BID, 7 Days

BMS-650032 in Healthy Subjects

Group Type ACTIVE_COMPARATOR

BMS-650032

Intervention Type DRUG

Capsules, Oral, 200 mg, BID, 7 Days

Interventions

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BMS-650032

Capsules, Oral, 200 mg, BID, 7 Days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Advanced Clinical Res Inst

Anaheim, California, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Countries

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United States

References

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Eley T, He B, Chang I, Colston E, Child M, Bedford W, Kandoussi H, Pasquinelli C, Marbury TC, Bertz RJ. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2015;20(1):29-37. doi: 10.3851/IMP2773. Epub 2014 Apr 7.

Reference Type DERIVED
PMID: 24704773 (View on PubMed)

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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AI447-012

Identifier Type: -

Identifier Source: org_study_id