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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01371162
First received: June 6, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 u p to 14 days (healthy volunteers).


Condition Intervention Phase
Hepatitis C, Chronic, Healthy Volunteer
Drug: RO5428029
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test) [ Time Frame: up to 17 days ] [ Designated as safety issue: No ]
  • Parts A + B: Safety: Incidence of adverse events [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]
  • Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC) [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371162

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01371162     History of Changes
Other Study ID Numbers: NP25733
Study First Received: June 6, 2011
Last Updated: August 4, 2014
Health Authority: France: AFSSAPS

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

ClinicalTrials.gov processed this record on August 25, 2014