Overview

Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
Summary
The overall study design includes two parts, Part A and Part B. Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hoffmann-La Roche
Criteria
Part A Inclusion:

- Male or female, ages 18 to 65 years

- No clinically significant abnormalities

- No serious or severe chronic conditions

- Non-smokers

Part A Exclusion:

- Female subjects who are pregnant or breast-feeding

- History of significant medical condition that could interfere with study medication or
associated study assessments

- History of or current drug or alcohol abuse

Part B Inclusion Criteria:

- Male or female, ages 18 to 65 years

- Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for
at least 6 months

- Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL

- Naïve to or have relapsed from prior IFN-alpha based therapy

Part B Exclusion Criteria:

- Female subjects who are pregnant or breast-feeding

- Received anti-viral therapy or immunomodulatory therapy within 90 days prior to
administration of the first dose of study medication

- Use of an investigational drug or participation in an investigational study with a
licensed drug within 30 days

- History of significant medical condition that could interfere with study medication or
associated study assessments

- History of or current drug or alcohol abuse