A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00722358
First received: July 23, 2008
Last updated: June 15, 2011
Last verified: June 2011
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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
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 May 16, 2013