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RO5508887

Phase 1

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

RO5508887 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Oct 2011

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

RO5508887 clinical trials

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?

RO5508887 is an investigational small molecule developed by Roche Holding AG. It has been studied in Phase 1 clinical trials in healthy volunteers rather than in patients with a specific disease. No therapeutic indication for RO5508887 has been disclosed.

Who is developing RO5508887?

RO5508887 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored all three of the Phase 1 studies conducted with this compound.

What phase is RO5508887 in?

RO5508887 is in Phase 1 development. All three of its recorded clinical trials were Phase 1 studies, and all three are now completed. The compound remains investigational and has not been approved by the FDA.

What clinical trials is RO5508887 in?

RO5508887 has been evaluated in three completed Phase 1 trials: NCT01664143 in France with 36 participants, NCT01592331 in the United States with 42 participants, and NCT01461967 in France with 49 participants. Together these studies enrolled 127 healthy volunteers.

What were the RO5508887 trials designed to measure?

The RO5508887 Phase 1 trials assessed safety, pharmacokinetics, and pharmacodynamics in healthy volunteers. NCT01461967 examined safety, pharmacokinetics, and pharmacodynamics; NCT01592331 focused on pharmacodynamic and pharmacokinetic measures; and NCT01664143 was a single-center study in healthy volunteers. All three were placebo-controlled and double-blind.