Roche trials database

Trial information

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

Status:

Completed

Protocol number:

NP25733

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official 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

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). Target sample size is 42.

Study phase:

I

Study type:

Interventional; Other; Randomized; Double Blind; Parallel; Safety study

Conditions:

• Healthy Volunteer
• Hepatitis C, Chronic

Primary outcome:

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

Key secondary outcomes:

1. 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

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

Gender:

Males or Females

Age limits:

Min: 18 years Max: 60 years

Accepts healthy volunteers:

No

Anticipated start date:

June, 2011

Trial registration date:

09.02.2011

Date last updated:

04.06.2013

This trial was conducted at the following locations:

France

• STRASBOURG

FRANCE

• Montpellier

NETHERLANDS

• LEIDEN

Poland

• CHORZOW

POLAND

• Warsaw
• Wroclaw

Link to trial result