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

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ClinicalTrials.gov Identifier: NCT00559247
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : September 13, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: BMS-650032 or Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: or Placebo - Dose Panel 1
Oral Suspension, 10 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 2
Oral Suspension 50 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 3
Oral Suspension, 200 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 4
Oral Suspension or Solution, 2.5 to 600 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose



Primary Outcome Measures :
  1. Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ]

Secondary Outcome Measures :
  1. Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559247


Locations
United States, California
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Maryland
Parexel International Corporation
Baltimore, Maryland, United States, 21225
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00559247     History of Changes
Other Study ID Numbers: AI447-002
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections