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This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | oral doses of danoprevir |
| |
| escitalopram |
| Measure | Description | Time Frame |
|---|---|---|
| Change in area under the plasma concentration time curve (AUC) of escitalopram | Approximately 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Approximately 6 weeks | |
| Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram | Approximately 4 weeks | |
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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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| Drug |
oral doses of escitalopram |
|
| ritonavir | Drug | oral doses of ritonavir |
|
| Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir |
| Approximately 4 weeks |
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D000089983 | Escitalopram |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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