Status:
COMPLETED
Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 i...
Detailed Description
Study Design: 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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01211626
Start Date
June 1 2008
End Date
August 1 2009
Last Update
November 14 2012
Active Locations (3)
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1
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands
2
PRA Clinical Research Unit
Groningen, Netherlands
3
Erasmus MC (EMC)
Rotterdam, Netherlands