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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018183-96 |
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This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: HV ascending dose | Experimental |
| |
| B: HV food effect | Experimental |
| |
| C: Hepatitis C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure | approximately 6 months | |
| Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713 | approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food intake on pharmacokinetics in healthy volunteers | Days 1-4 | |
| Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients | From baseline to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grafton | 1010 | New Zealand |
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| RO5303253 | Drug | Cohorts receiving single ascending doses |
|
| RO5303253 | Drug | Single dose |
|
| RO5303253 | Drug | Multiple doses |
|
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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