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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
History of Changes
  Purpose

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 Intervention Phase
Chronic Hepatitis C
 Drug: BMS-650032 or Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00559247     History of Changes
Other Study ID Numbers: AI447-002
Study First Received: November 15, 2007
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013