Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients (CBZF961X2201)

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis C

Treatments

Drug: Ritonavir

Drug: BZF961

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01825980

CBZF961X2201

2012-003103-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Volunteers

No Healthy Volunteers

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.