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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002283-28 | EudraCT Number |
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This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: setrobuvir | Experimental |
| |
| B: setrobuvir + DNV/r | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | 100 mg orally every 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 40 days | |
| Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) | up to 16 days | |
| Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h) | up to 16 days | |
| Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h) | up to 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Time to maximum plasma concentration (tmax) | up to 16 days | |
| Pharmacokinetics: Elimination half-life (t1/2) | up to 16 days | |
| Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F) |
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Inclusion Criteria:
Medical history without major recent or ongoing pathology Laboratory values at screening and Day -1 within the normal range or showing no clinically relevant deviations
Stable mild liver disease (Child-Pugh A) of cryptogenic, post-hepatic, hepatitis B/C, or alcoholic origin Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days Must be on stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balatonfüred | 8230 | Hungary | ||||
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| ritonavir |
| Drug |
100 mg orally every 12 hours |
|
| setrobuvir | Drug | 200 mg orally every 12 hours |
|
| up to 16 days |
| Pharmacokinetics: Cumulative amount excreted at steady-state (Aess) | up to 16 days |
| Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f) | up to 16 days |
| Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC) | up to 12 days |
| Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC) | up to 12 days |
| Budapest |
| 1076 |
| Hungary |
| Warsaw | 01-201 | Poland |
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| C000592794 | setrobuvir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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