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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722358
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : June 27, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: BMS-650032 Drug: BMS-650032

Capsule, Oral, Q12h, 3/5 days

Panel 1: 200 mg

Panel 2: 400 mg

Panel 3: 600 mg

Placebo Comparator: Placebo Drug: Placebo

Capsule, Oral, Q 12h, 3/5 days

Panel 1: matching placebo

Panel 2: matching placebo

Panel 3: matching placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 [ Time Frame: 28 days after drug ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00722358

United States, California
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
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, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Puerto Rico
Local Institution
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00722358     History of Changes
Other Study ID Numbers: AI447-004
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

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