Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antiviral Agents; Ritonavir

Criteria

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.