Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00722358
First received: July 23, 2008
Last updated: June 15, 2011
Last verified: June 2011

July 23, 2008
June 15, 2011
December 2008
December 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period ] [ Designated as safety issue: No ]
Pharmacodynamic Measures: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline [ Time Frame: The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 7 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00722358 on ClinicalTrials.gov Archive Site
  • PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 [ Time Frame: 28 days after drug ] [ Designated as safety issue: Yes ]
  • Safety Outcome Measures: Safety and tolerability assessments [ Time Frame: will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic Measures: Pharmacokinetic assessments [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Safety Outcome Measures: Safety and tolerability assessments [ Time Frame: will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic Measures: Pharmacokinetic assessments [ Time Frame: will be done on Day 1 for one dosing interval after the AM dose and on Day 7 for 72 hours after the last AM dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: BMS-650032

    Capsule, Oral, Q12h, 3/5 days

    Panel 1: 200 mg

    Panel 2: 400 mg

    Panel 3: 600 mg

  • 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
    Intervention: Drug: BMS-650032
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00722358
AI447-004
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP