A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects (Part A), and in Chronic Hepatitis C Genotype 1 Infected Patients (Part B).

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects (Part A), and in Chronic Hepatitis C Genotype 1 Infected Patients (Part B). - RO5428029 in Chronic Hepatitis C Genotype 1 Infected Patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36081

Enrollment

Registered

2011-07-07

Start date

2011-09-26

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

Proposed dosing schedule: Cohort B1: 1000 mg BID/ 7 days Cohort B2: to be decided /7 days Cohort B3: to be decided /7 days Cohort B4: to be decided /7days Cohort B5: to be decided 7days The doses in

Eligibility

Age

18 Years to 99 Years

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

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
- Safety and tolerability: AEs, 12-lead ECGs, vital signs and laboratory tests - PK parameters: Cmax, AUC, Tmax and Cmin of RO1080713 - HCV RNA levels - Resistance emergence	—

Secondary

Measure	Time frame
- PK: Other pharmacokinetic parameters of RO1080713 - PK: Pharmacokinetic parameters of RO5428029 and/or other metabolites as needed	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)