Hepatitis C
Conditions
Brief summary
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
Interventions
DRUGBZF961
There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.
DRUGRitonavir
Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any assessment is performed Male & female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1. Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the investigator, to understand and comply with the study requirements.
Exclusion criteria
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. Subjects that were previously treated for HCV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV viral load | Day 3 | Viral load samples will be taken at Day 3. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events as a measure of safety | 2 weeks |
| Total BZF961 concentration in plasma | Day 4 |
Countries
United States
Outcome results
None listed