Chronic Hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: n.a.
Product Code: RO5428029/F01
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO5428029
Other descriptive name: HCV Polymerase 9
Concentration unit: mg milligram(s)
Conc
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability and pharmacokinetic properties of RO5428029 in healthy subjects and chronic hepatitis C genotype 1 infected patients. To evaluate pharmacodynamics (viral load response) of RO5428029 in chronic hepatitis C genotype 1 patients. ;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: Safety and tolerability PK Parameters Part B: Safety and tolerability PK Parameters HCV RNA levels Resistance emergence ;Timepoint(s) of evaluation of this end point: Please refer to Protocol NP25733, section 5, Schedule of Assessments and Schedule of Procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands, Poland
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed