Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00971308
First received: September 2, 2009
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.


Condition Intervention Phase
Chronic Hepatitis C
Drug: BMS-824393
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive 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:
  • Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects [ Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects [ Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration ] [ Designated as safety issue: Yes ]
  • To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b) [ Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of multiple oral doses of BMS-824393 [ Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-824393 (Panel 1) Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 2) Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 3) Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 4) Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 5) Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
  • HCV RNA viral load of ≤10*5* IU/mL (100,000 IU/mL)
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
  • Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study
  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: NCT00971308

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
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:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00971308     History of Changes
Other Study ID Numbers: AI451-002
Study First Received: September 2, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014