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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722358
• Other study ID #: AI447-004
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: June 15, 2011
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BMS-650032
Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg
• Placebo
Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo

Locations

Country	Name	City	State
Puerto Rico	Local Institution	Santurce
United States	Advanced Clinical Res Inst	Anaheim	California
United States	Central Texas Clinical Research	Austin	Texas
United States	Parexel International Corporation	Baltimore	Maryland
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032		28 days after drug	Yes
Secondary	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	Yes
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form