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