A Single 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:
NCT00559247
First received: November 15, 2007
Last updated: September 10, 2010
Last verified: September 2010

November 15, 2007
September 10, 2010
January 2008
July 2008   (final data collection date for primary outcome measure)
Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ] [ Designated as safety issue: Yes ]
Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ]
Complete list of historical versions of study NCT00559247 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic Measures [ Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ]
  • Pharmacodynamic Measures [ Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing ]
Not Provided
Not Provided
 
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
  • Experimental: or Placebo - Dose Panel 1
    Oral Suspension, 10 mg
    Intervention: Drug: BMS-650032 or Placebo
  • Experimental: or Placebo - Dose Panel 2
    Oral Suspension 50 mg
    Intervention: Drug: BMS-650032 or Placebo
  • Experimental: or Placebo - Dose Panel 3
    Oral Suspension, 200 mg
    Intervention: Drug: BMS-650032 or Placebo
  • Experimental: or Placebo - Dose Panel 4
    Oral Suspension or Solution, 2.5 to 600 mg
    Intervention: Drug: BMS-650032 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
  • Co-infection with HIV or HBV
  • Women of childbearing potential
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00559247
AI447-002
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2010

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