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Completed

NCT Number: NCT01019070

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

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

Completed

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Clinical Res Inst, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-650032

Drug

Capsules, Oral, 200 mg, BID, 7 Days

Primary outcomes

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

    Time frame: Day 10

Secondary outcomes

  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

    Time frame: 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.

    Time frame: Day 10

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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