A Multiple 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:
NCT00722358
First received: July 23, 2008
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 [ Time Frame: 28 days after drug ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722358

Locations
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00722358     History of Changes
Other Study ID Numbers: AI447-004
Study First Received: July 23, 2008
Last Updated: June 15, 2011
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 July 22, 2014