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

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: BMS-650032; Drug: Placebo

• Registration Number: NCT00722358
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Study Start: 2008-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-15
• Disposition First Submitted QC: 2011-06-15
• Last Update Submitted: 2011-06-15
• Disposition First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Chronically infected with HCV genotype 1
• Treatment naive
• HCV RNA viral load of ≥10*5 IU/mL
• BMI 18 to 35kg/m²

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-650032	BMS-650032	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032	28 days after drug
Safety Outcome Measures: Safety and tolerability assessments	will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days
Pharmacokinetic Measures: Pharmacokinetic assessments	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

Trial Locations

Locations (5)

Advanced Clinical Res Inst; 🇺🇸 Anaheim, California, United States

Local Institution; 🇵🇷 Santurce, Puerto Rico

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Parexel International Corporation; 🇺🇸 Baltimore, Maryland, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States