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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01371162
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic, Healthy Volunteer Drug: RO5428029 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : June 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A1 Healthy Volunteers Drug: RO5428029
Multiple ascending doses
Placebo Comparator: A2 Drug: placebo
multiple doses
Experimental: B1 HCV Infection Drug: RO5428029
Multiple ascending doses
Placebo Comparator: B2 Drug: placebo
multiple doses

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01371162

Montpellier, France, 34094
Strasbourg, France, 67064
Leiden, Netherlands, 2333
Chorzow, Poland, 41-500
Warsaw, Poland, 01-201
Wrocław, Poland, 50-349
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01371162     History of Changes
Other Study ID Numbers: NP25733
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic