drugset / Trial / NCT01211626

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

NCT01211626 ↗

Phase 1 Completed 75 enrolled Hoffmann-La Roche
RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start
2008-06
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator RG-7795 Unknown 200 mg Oral
Comparator RG-7795 Unknown 400 mg Oral
Comparator RG-7795 Unknown 800 mg Oral
Comparator RG-7795 Unknown 1200 mg Oral
Comparator RG-7795 Unknown 1600 mg Oral
Comparator RG-7795 Unknown 2000 mg Oral