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RO5267683

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

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

RO5267683 · 1 trial · 1 indication

Phase 1 1
NCT01398241A Study of RO5267683 in Healthy SubjectsHealthy Volunteer
COMPLETED38 Analytics
PHASE1COMPLETED
A Study of RO5267683 in Healthy Subjects
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Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
14 weeks

Secondary Endpoints

Pharmacokinetics: Plasma concentrations
14 weeks
Pharmacokinetics: Urine concentrations
4 weeks
Lipid levels in the blood
14 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RO5267683DRUGMultiple ascending doses
placeboDRUGMultiple ascending doses
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects, 18 to 45 years of age, * Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening * Female subjects must be surgically sterile or post-menopausal * Male subjects must use a barrier method of contraception for ...

Countries:France
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Frequently asked questions about RO5267683

What is RO5267683 used for?

RO5267683 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated the drug in healthy subjects to assess its safety and tolerability.

Who makes RO5267683?

RO5267683 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 study of the drug in healthy volunteers.

What phase is RO5267683 in?

RO5267683 is in Phase 1 clinical development. The single trial listed for the drug is a Phase 1 study that has been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is RO5267683 in?

RO5267683 has one completed clinical trial, NCT01398241, titled 'A Study of RO5267683 in Healthy Subjects'. This Phase 1 study enrolled 38 participants in France and was placebo-controlled, randomized, and double-blind.

Is RO5267683 FDA approved?

RO5267683 is not FDA approved. It is an investigational drug that has only been studied in a Phase 1 clinical trial in healthy volunteers. The trial is completed, but the drug has not progressed to later-stage studies or received marketing approval.