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

A Single Ascending Dose Study of BMS-790052 in HCV Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546715
First received: October 17, 2007
Last updated: September 10, 2013
Last verified: September 2013

October 17, 2007
September 10, 2013
November 2007
May 2008   (final data collection date for primary outcome measure)
  • Number of Participants With Death as an Outcome, Serious Adverse Events (SAEs), Treatment-related Adverse Events (AEs), AEs, and Discontinuations Due to AEs [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Vital Sign Measurements and Physical Examination Findings [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Clinical Laboratory Findings [ Time Frame: Days 1 through 7 ] [ 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 NCT00546715 on ClinicalTrials.gov Archive Site
  • Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C12)and at 24 Hours (C24) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve from Time Zero (AUC[INF]) extrapolated to infinite time [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Plasma Half-life (T-half) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Apparent Total Body Clearance (CLT/F) [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Magnitude and Rate of Change in Plasma Hepatitis C Virus(HCV) RNA Levels From Baseline [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Change in Blood Pressure From Baseline [ Time Frame: From first dose to a maximum of 72 hours ] [ Designated as safety issue: No ]
  • Change in Electrocardiogram (ECG) Parameters (Heart Rate, PR, QRS, QT, and QTc Intervals) [ Time Frame: At screening, Day -1, Day 1, Day 3, and Day 7 ] [ Designated as safety issue: No ]
  • Time of Cmax (Tmax) [ Time Frame: From first dose to a maximum of 72 hours ] [ 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-790052 in HCV Infected Subjects
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-790052 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-790052 in subjects with chronic hepatitis C infection

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: BMS-790052
    Oral Solution, Oral, Single Dose
  • Drug: Placebo
    Oral Solution, Oral, Single Dose
  • Active Comparator: Dose Panel A

    BMS-790052 - 1 mg

    Placebo - 0 mg

    Interventions:
    • Drug: BMS-790052
    • Drug: Placebo
  • Active Comparator: Dose Panel B

    BMS-790052 - 10 mg

    Placebo - 0 mg

    Interventions:
    • Drug: BMS-790052
    • Drug: Placebo
  • Active Comparator: Dose Panel C

    BMS-790052 - 100 mg

    Placebo - 0 mg

    Interventions:
    • Drug: BMS-790052
    • Drug: Placebo
  • Active Comparator: Dose Panel D

    BMS-790052 - 0.5 - 200 mg (to be determined)

    Placebo - 0 mg

    Interventions:
    • Drug: BMS-790052
    • 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
19
May 2008
May 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; and not co-infected with HIV or HBV
  • 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
Both
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00546715
AI444-002
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2013

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