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RO5267683

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Nov 2, 2016

RO5267683 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2011

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

RO5267683 clinical trials

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?

RO5267683 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.

Who makes RO5267683?

RO5267683 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program for this investigational small molecule.

What phase is RO5267683 in?

RO5267683 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program has completed one Phase 1 trial, and no active trials are currently listed.

What clinical trials is RO5267683 in?

RO5267683 has been evaluated in one clinical trial, NCT01398241, titled A Study of RO5267683 in Healthy Subjects. This completed Phase 1 trial enrolled 38 healthy adult volunteers in France. It was randomized, double-blind, and placebo-controlled.

What is RO5267683 used for?

RO5267683 is an investigational drug, and the specific indication it is being developed to treat has not been disclosed. Its only reported clinical study was conducted in healthy volunteers rather than in patients with a defined disease.

How was the RO5267683 Phase 1 trial designed?

The Phase 1 trial of RO5267683, NCT01398241, was a randomized, double-blind, placebo-controlled study in healthy subjects. It enrolled 38 participants of all sexes, aged 18 years and older, at sites in France. The trial has been completed.