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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001413-13 | EudraCT Number |
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This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
| |
| D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | 100 mg single dose orally |
| |
| danoprevir |
| Measure | Description | Time Frame |
|---|---|---|
| Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose | approximately 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma concentrations | approximately 9 weeks | |
| Safety: Incidence of adverse events | approximately 9 weeks | |
| Cardiac response: Electrocardiogram (ECG) |
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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 |
|---|---|---|---|---|---|---|
| Strasbourg | 67064 | France |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D000077266 | Moxifloxacin |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
400 mg single dose orally |
|
| danoprevir placebo | Drug | single oral dose |
|
| moxifloxacin | Drug | 400 mg single dose orally |
|
| moxifloxacin placebo | Drug | single oral dose |
|
| ritonavir | Drug | 100 mg single dose orally |
|
| ritonavir placebo | Drug | single oral dose |
|
| approximately 9 weeks |
| Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes | approximately 9 weeks |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |