Clinical trial NCT01371162: A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic, Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


Eligibility 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

Primary outcomes:
measure: Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
timeFrame: up to 17 days
measure: Parts A + B: Safety: Incidence of adverse events
timeFrame: up to 24 days
measure: Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
timeFrame: up to 24 days
Secondary outcomes:
measure: Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
timeFrame: up to 17 days
Other outcomes:
Locations:
city: Montpellier
country: France
city: Strasbourg
country: France
city: Leiden
country: Netherlands
city: Chorzow
country: Poland
city: Warsaw
country: Poland
city: Wrocław
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: