Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
setrobuvir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A: STV capsule (after high fat meal) | ACTIVE_COMPARATOR | - |
| B: STV capsule (fasted state) | ACTIVE_COMPARATOR | - |
| C: STV tablet (after high fat meal) | EXPERIMENTAL | - |
| D: STV tablet (fasted state) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| setrobuvir | DRUG | 200 mg capsule formulation, single oral dose |
Inclusion Criteria: * Healthy male and female adults, 18 to 55 years of age inclusive * Body mass index (BMI) 18.0 - 30.0 kg/m2 * Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination * Females of ch...
Setrobuvir is an investigational small molecule developed by Roche Holding AG for chronic hepatitis C. It is a Phase 1 asset and has not been approved for any indication. Development work has focused on oral dosing, including tablet and capsule formulations studied in healthy volunteers.
Setrobuvir was being developed for the treatment of chronic hepatitis C, a viral infection of the liver. It is an investigational therapy and is not approved for use in chronic hepatitis C or any other condition. Clinical work to date has centered on formulation and bioavailability rather than treatment outcomes.
Setrobuvir is developed by Roche Holding AG, the Swiss pharmaceutical company whose shares trade over the counter in the United States under the ticker RHHBY. Roche sponsored the clinical study of the compound. No other developer or partner is identified for this asset.
Setrobuvir is in Phase 1 development. Its single recorded trial, NCT01612143, was a Phase 1 study that has been completed, and no trials are currently active. The compound remains investigational and has not received FDA approval for chronic hepatitis C or any other indication.
Setrobuvir has been studied in one completed Phase 1 trial, NCT01612143. That study compared a setrobuvir tablet formulation against a reference capsule formulation in 40 healthy volunteers in the Netherlands. It was randomized and active controlled, with participants aged 18 years and older. No setrobuvir trials are currently active.