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NCT Number: NCT01371162

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

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).

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Key information

Conditions

Hepatitis C, Chronic, Healthy Volunteer Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Communicable Diseases Digestive System Diseases Flaviviridae Infections Graft vs Host Disease Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5428029

Drug

Multiple ascending doses

Placebo

Drug

multiple doses

Primary outcomes

  1. Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)

    Time frame: up to 17 days

  2. Parts A + B: Safety: Incidence of adverse events

    Time frame: up to 24 days

  3. Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)

    Time frame: up to 24 days

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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