Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000470-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: iv danoprevir | Experimental |
| |
| Part 1: placebo | Placebo Comparator |
| |
| Part 2 A: iv danoprevir | Experimental |
| |
| Part 2 B: oral danoprevir | Active Comparator |
| |
| Part 2 C: ritonavir | Active Comparator |
| |
| Part 3 D: iv danoprevir | Experimental |
| |
| Part 3 E: iv danoprevir + cyclosporine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | single iv infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 12 hours post-dose | |
| Safety: Incidence of adverse events | approximately 7 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
Not provided
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| danoprevir | Drug | single oral dose |
|
| placebo | Drug | single iv infusion |
|
| ritonavir | Drug | oral doses |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |