A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01371162
First received: June 6, 2011
Last updated: December 3, 2012
Last verified: December 2012
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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 up 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:
- 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 ]
- 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 ]
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: | March 2012 |
| Primary Completion Date: | March 2012 (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
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, 51-149 | |
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: | December 3, 2012 |
| 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 May 16, 2013