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This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S1 P1 TDF + DNV/r | Experimental |
| |
| S1/S2 P2 DNV/r + ATZ | Experimental |
| |
| S2 P1 ATZ/r | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atazanavir | Drug | multiple oral doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC) | Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20 | |
| Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC) | Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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| danoprevir |
| Drug |
multiple oral doses |
|
| ritonavir | Drug | multiple oral doses |
|
| tenofovir disoproxil fumarate | Drug | single oral doses |
|
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| C553752 | danoprevir |
| D019438 | Ritonavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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