Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00971308
First received: September 2, 2009
Last updated: January 24, 2011
Last verified: January 2011
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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
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, 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