Chronic Hepatitis C
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
Interventions
DRUGBMS-791325
Capsules, Oral, Once Daily, Single Dose
DRUGPlacebo
Capsules, Oral, Once Daily, Single Dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Chronically infected with HCV genotype 1 * Treatment naive or treatment non-responders or treatment intolerant * HCV RNA viral load of ≥10\*5\* IU/mL * BMI 18 to 35 kg/m²
Exclusion criteria
* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection * Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug * Co-infection with HIV or HBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Outcome Measures | Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Measures | Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose |
| Pharmacodynamic Measures | Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing |
Countries
Argentina, United States
Outcome results
None listed