A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: BMS-650032; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Santurce, Puerto Rico, 00909
    • Local Institution
• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Res Inst
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel International Corporation
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronically infected with HCV genotype 1
• Treatment naive
• HCV RNA viral load of ≥10*5 IU/mL
• BMI 18 to 35kg/m²

Exclusion Criteria:

• Women of childbearing potential (WOCBP)
• Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
• HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
• HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
• HIV and/or HBV positive
• Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo
Active Comparator: BMS-650032	Drug: BMS-650032; Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5	To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period

Secondary Outcome Measures

Outcome Measure	Time Frame
PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032	28 days after drug
Safety Outcome Measures: Safety and tolerability assessments	will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days
Pharmacokinetic Measures: Pharmacokinetic assessments	will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Asunaprevir
• Other Study ID Numbers: AI447-004