Clinical trial NCT00722358: A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period
Secondary outcomes:
measure: PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032
timeFrame: 28 days after drug
measure: Safety Outcome Measures: Safety and tolerability assessments
timeFrame: will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days
measure: Pharmacokinetic Measures: Pharmacokinetic assessments
timeFrame: 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
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Res Inst
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Baltimore
country: United States
facility: Parexel International Corporation
state: Maryland
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Santurce
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: