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This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers. Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days, danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days 18-21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 Control | Active Comparator |
| |
| Period 2 danoprevir/ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | 100 mg q12h Days 8-21 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC) | approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose Days 8. 14, 15, 16 and 20, pre-and up to 24 h post-dose Days 17 and 21 | |
| Safety: Incidence of adverse events | approximately 2 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 |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| D000068898 | Raltegravir Potassium |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| raltegravir |
| Drug |
400 mg q12h Days 1-4 and 18-21 |
|
| ritonavir | Drug | 100 mg q12h Days 8-21 |
|
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |