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setrobuvir

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

setrobuvir · 1 trial · 1 indication

Phase 1 1
NCT01612143A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy VolunteersHealthy Volunteer
COMPLETED40 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Relative bioavailability: Cmax/area under the concentration-time curve (AUC)
Pre-dose and up to 168 hours post-dose

Secondary Endpoints

Safety: Incidence of adverse events
approximately 2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
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 -

Interventions

NameTypeDescription
setrobuvirDRUG200 mg capsule formulation, single oral dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Netherlands
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Frequently asked questions about setrobuvir

What is setrobuvir used for?

Setrobuvir is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and remains in clinical development. The completed Phase 1 trial evaluated the drug in healthy volunteer subjects to assess the relative bioavailability of different formulations.

Who makes setrobuvir?

Setrobuvir is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is setrobuvir in?

Setrobuvir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is setrobuvir in?

Setrobuvir has one completed clinical trial, NCT01612143, titled "A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers." This Phase 1 study enrolled 40 participants in the Netherlands and was active-controlled.

Is setrobuvir the same as any other drug?

No alternative names for setrobuvir have been reported. The drug is known only by the name setrobuvir in clinical development records.