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RO6806127

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-BlindCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

RO6806127 · 1 trial · 1 indication

Phase 1 1
NCT02196636A Phase 1 Study of RO6806127 in Healthy Male VolunteersHealthy Volunteer
COMPLETED37 Analytics
PHASE1COMPLETED
A Phase 1 Study of RO6806127 in Healthy Male Volunteers
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Study Endpoints

Primary Endpoints

Incidence of adverse events
Up to Day 21

Secondary Endpoints

Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine
Up to Day 21
RO6806127 metabolite concentrations in selected plasma and urine samples
Up to Day 21
Relative bioavailability (food effect): Area under the concentration-time curves [AUC]
Up to Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Part 1: Single Ascending Dose (SAD)EXPERIMENTALAdaptive model per protocol
Part 2: Food Effect (FE)EXPERIMENTALFasted versus Fed

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo, administered orally with approximately 240 mL of buffer
RO6806127DRUGAdministered orally with approximately 240 mL of buffer
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male participants aged 18 to 45 years, inclusive * A BMI between 18 to 30 kg/m2, inclusive * Agreement to use highly effective contraception Exclusion Criteria: * Clinically significant abnormalities in laboratory test results * History of any clinically significant ...

Countries:United States
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Frequently asked questions about RO6806127

What is RO6806127 used for?

RO6806127 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated the drug in healthy male participants to assess its safety and tolerability.

What does RO6806127 target?

The molecular target of RO6806127 has not been disclosed. It is a small molecule modality, but its specific biological target is not publicly available from the clinical trial information.

Who makes RO6806127?

RO6806127 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is RO6806127 in?

RO6806127 is in Phase 1 clinical development. The single Phase 1 study, NCT02196636, has been completed. The drug remains investigational and has not received FDA approval.

What clinical trials is RO6806127 in?

RO6806127 has one completed clinical trial, NCT02196636, titled 'A Phase 1 Study of RO6806127 in Healthy Male Volunteers.' This randomized, double-blind, controlled study enrolled 37 healthy male participants aged 18 years and older in the United States.

Is RO6806127 the same as any other drug?

No alternative names for RO6806127 have been disclosed. The drug is identified solely by its code name RO6806127 in clinical trial records, and no other names or aliases are associated with it.