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RO5508887

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 Trials3
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

RO5508887 · 3 trials · 1 indication

Phase 1 3
NCT01664143A Single-Center Study of RO5508887 in Healthy VolunteersHealthy Volunteer
COMPLETED36 Analytics
NCT01592331A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy VolunteersHealthy Volunteer
COMPLETED42 Analytics
NCT01461967A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy VolunteersHealthy Volunteer
COMPLETED49 Analytics
PHASE1COMPLETED
A Single-Center Study of RO5508887 in Healthy Volunteers
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: incidence of adverse events
30 days
Plasma levels of amyloid biomarkers
Pre-dose and up to fullow up, 8-12 days post dose
Cerebral spinal fluid levels of amyloid biomarkers
Pre-dose and up to 30 hours post-dose
Safety/tolerability: Incidence of adverse events
up to approximately 8 weeks

Secondary Endpoints

Correlation of the age on pharmacokinetics of RO5508887
30 days
Correlation of the age on pharmacodynamics of RO5508887
30 days
Pharmacokinetics: plasma levels of RO5508887
Predose and up to 144 hours post last dose, and at follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5508887EXPERIMENTAL -
Part 1aEXPERIMENTAL -
Part 1bPLACEBO_COMPARATOR -
Part 2EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGMultiple doses of placebo
RO5508887DRUGMultiple doses of RO5508887
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult healthy volunteers, \>/=18 years of age * Body mass index (BMI) between 18 and 30 kg/m2 inclusive * Use of adequate contraception methods or surgically sterile Exclusion Criteria: * Evidence of active or chronic disease * Regular consumption of drugs of abuse * Regular...

Countries:FranceUnited States
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Frequently asked questions about RO5508887

What is RO5508887 used for?

RO5508887 is an investigational small molecule being studied in healthy volunteers. It has been evaluated in Phase 1 clinical trials to assess its safety, pharmacokinetics, and pharmacodynamics. The drug is not approved for any condition and remains in clinical development.

Who makes RO5508887?

RO5508887 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple Phase 1 trials of this investigational small molecule in healthy volunteers.

What phase is RO5508887 in?

RO5508887 is in Phase 1 clinical development. All three completed trials of the drug were Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO5508887 in?

RO5508887 has been studied in three completed Phase 1 trials: NCT01461967, NCT01592331, and NCT01664143. These trials enrolled a total of 127 healthy volunteers and were conducted in France and the United States.

Is RO5508887 the same as any other drug?

RO5508887 is the only name provided for this investigational drug. No alternative names have been identified in the available information. It is a small molecule being developed by Roche Holding AG.

How does RO5508887 work?

The mechanism of action of RO5508887 has not been disclosed in the available information. It is a small molecule being studied in healthy volunteers for its safety, pharmacokinetics, and pharmacodynamics in Phase 1 trials.