A multi-center study to assess the safety, tolerability and drug levels in the human body in healthy volunteers (part A) and patients with Chronic Hepatitis C Genotype 1 (part B)
- Conditions
- Chronic Hepatitis CMedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000640-24-NL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
- Female subjects/patients must be surgically sterile or post-menopausal
- Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
- For HCV patients:
- Hepatitis C genotype 1 of >/= 6 months duration at screening
- HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
- HCV treatment-naïve
- Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Pregnant or lactating women, and male partners of women who are pregnant or lactating
- Women with reproductive potential
- Positive test for drugs of abuse
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
- History or symptoms of any significant disease or disorder
- History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
- Positive for hepatitis B or HIV infection, and/ or HCV for healthy volunteers (Part A)
- For HCV patients:
- Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
- Evidence of cirrhosis and/or incomplete transition to cirrhosis
- Presence or history of non-hepatitis C liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety, tolerability and pharmacokinetic properties of RO5428029 in healthy subjects and chronic hepatitis C genotype 1 infected patients.<br>To evaluate pharmacodynamics (viral load response) of RO5428029 in chronic hepatitis C genotype 1 patients.<br>;Secondary Objective: To monitor the resistance profile of RO5428029 and evaluate potential relationship of baseline susceptibility of the virus with antiviral response in chronic hepatitis C genotype 1 patients.;Primary end point(s): Part A:<br>Safety and tolerability<br>PK Parameters<br><br>Part B:<br>Safety and tolerability<br>PK Parameters<br>HCV RNA levels<br>Resistance emergence<br>;Timepoint(s) of evaluation of this end point: Please refer to Protocol NP25733, section 5, Schedule of Assessments and Schedule of Procedures
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Other pharmacokinetic parameters;Timepoint(s) of evaluation of this end point: Please refer to Protocol NP25733, section 5, Schedule of Assessments and Schedule of Procedures