Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
- Registration Number
- NCT01825980
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description BZF961 BZF961 - Placebo Placebo - BZF961 Ritonavir -
- Primary Outcome Measures
Name Time Method HCV viral load Day 3 Viral load samples will be taken at Day 3.
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety 2 weeks Total BZF961 concentration in plasma Day 4
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸San Antonio, Texas, United States