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| ID | Type | Description | Link |
|---|---|---|---|
| RPU425UD-114254 | Other Identifier | PRA International |
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This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 A | Active Comparator |
| |
| Part 1 B | Experimental |
| |
| Part 1 C | Experimental |
| |
| Part 2 D | Active Comparator |
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| Part 2 E | Experimental |
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| Part 2 F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | Phase 3 Tablet Formulation 1, single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) | 24 hours | |
| Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) | 24 hours | |
| Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC) | 24 hours | |
| Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 4 months |
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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 |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| danoprevir |
| Drug |
Phase 3 Tablet Formulation 2, single oral dose |
|
| danoprevir | Drug | Reference Phase 2 Tablet Formulation, single oral dose |
|
| ritonavir | Drug | Test Formulation 1, single oral dose |
|
| ritonavir | Drug | Test Formulation 2, single oral dose |
|
| ritonavir | Drug | Reference Formulation, single oral dose |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |