Hepatitis C
Conditions
Keywords
Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy
Brief summary
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.
Interventions
DRUGLCQ908
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent. * Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3). * No prior therapy or inadequate response to therapy for hepatitis C. * Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.
Exclusion criteria
* Use of other investigational drugs within at least 30 days of enrollment * Women of child-bearing potential. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Change in hepatitis C viral load as assessed by PCR | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events. | 28 days |
| Measure: LCQ908 concentrations in the blood | over 21 days |
Countries
New Zealand
Outcome results
None listed