A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01371162
• Date of registration: 06/06/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
• Scientific title: 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 and in CHC Genotype 1 Infected Patients
• Date of first enrolment: June 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01371162
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

France, Netherlands, Poland, Romania

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 (no prior antiviral therapy for chronic hepatitis C with
interferon-based therapy)

- Liver biopsy or non-invasive procedure within the past 2 years showing absence of
cirrhosis

Exclusion Criteria:

- Pregnant or lactating women, and male partners of women who are pregnant or lactating

- 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 for 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic, Healthy Volunteer

Intervention(s)

Drug: RO5428029

Drug: placebo

Primary Outcome(s)

Parts A + B: Safety: Incidence of adverse events [Time Frame: up to 24 days]

Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test) [Time Frame: up to 17 days]

Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC) [Time Frame: up to 24 days]

Secondary Outcome(s)

Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test [Time Frame: up to 17 days]

Secondary ID(s)

NP25733

Source(s) of Monetary Support

Please refer to primary and secondary sponsors