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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01371162

Enrollment

Registered

2011-06-10

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2016-11-02

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

Conditions

Hepatitis C, Chronic, Healthy Volunteer

Brief summary

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

Interventions

DRUGRO5428029

Multiple ascending doses

DRUGplacebo

multiple doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)	up to 17 days
Parts A + B: Safety: Incidence of adverse events	up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)	up to 24 days

Secondary

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

Countries

France, Netherlands, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026