Chronic Hepatitis C
Conditions
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
Interventions
DRUGBMS-650032
Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg
DRUGPlacebo
Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Puerto Rico, United States
Outcome results
None listed