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RO6870868

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Jul 26, 2018

RO6870868 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2013

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

RO6870868 clinical trials

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
Healthy VolunteerUnlock trial analytics

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?

RO6870868 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease or condition it is intended to treat has not been disclosed, so its therapeutic use is not publicly defined.

Who makes RO6870868?

RO6870868 is 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 compound.

What phase is RO6870868 in?

RO6870868 is in Phase 1 development. It is an investigational drug and is not approved for any indication. The program has completed one Phase 1 trial, and no active trials are currently listed for this compound.

What clinical trials is RO6870868 in?

RO6870868 has been evaluated in one completed Phase 1 trial, NCT01911611, titled A Study of RO6870868 in Healthy Volunteers. The trial enrolled 60 participants in the Netherlands, was randomized, double blind, and placebo controlled, and included adults 18 years and older.

Was the RO6870868 trial conducted in healthy volunteers?

Yes. The Phase 1 trial NCT01911611 for RO6870868 was conducted in healthy volunteers rather than in patients with a specific disease. It enrolled 60 participants, used a randomized, double blind, placebo controlled design, and was run in the Netherlands. The study has been completed.