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RO6870868

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Jul 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

RO6870868 · 1 trial · 1 indication

Phase 1 1
NCT01911611A Study of RO6870868 in Healthy VolunteersHealthy Volunteer
COMPLETED60 Analytics
PHASE1COMPLETED
A Study of RO6870868 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
up to 44 days

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC)
Pre-dose and up to 48 hours post-dose
Pharmacokinetics: Maximum plasma concentration (Cmax)
Pre-dose and up to 48 hours post-dose
Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC)
Pre-dose and up to 48 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO6870868EXPERIMENTAL -

Interventions

NameTypeDescription
RO6870868DRUGSingle ascending doses
placeboDRUGSingle ascending doses
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination * Women of non-childbearing potential inc...

Countries:Netherlands
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Frequently asked questions about RO6870868

What is RO6870868 used for?

RO6870868 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial evaluated its safety and tolerability in healthy adults, not for a specific medical condition.

Who makes RO6870868?

RO6870868 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 study of the drug in healthy volunteers in the Netherlands.

What phase is RO6870868 in?

RO6870868 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to the available data.

What clinical trials is RO6870868 in?

RO6870868 has one completed clinical trial, NCT01911611, titled "A Study of RO6870868 in Healthy Volunteers." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 60 healthy adults aged 18 years and older in the Netherlands.

Is RO6870868 FDA approved?

No, RO6870868 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 remains in clinical development and has not been approved for any use.