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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg
Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo
Advanced Clinical Res Inst
Anaheim, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Parexel International Corporation
Baltimore, Maryland, United States
Central Texas Clinical Research
Austin, Texas, United States
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
PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032
Time frame: 28 days after drug
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
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
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Local Institution
Santurce, Puerto Rico