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RO6806127

Phase 1

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

RO6806127 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2014

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

RO6806127 clinical trials

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?

RO6806127 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy male volunteers. The specific disease indications for which it is being developed have not been disclosed, and it remains in early clinical development.

Who makes RO6806127?

RO6806127 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the Phase 1 study evaluating the compound in healthy male volunteers.

What phase is RO6806127 in?

RO6806127 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is RO6806127 in?

RO6806127 has been evaluated in one Phase 1 trial, NCT02196636, titled A Phase 1 Study of RO6806127 in Healthy Male Volunteers. The trial was completed, enrolled 37 participants, was randomized, double blind, and controlled, and was conducted in the United States.

What is RO6806127 used for?

RO6806127 is an investigational agent that has been studied in healthy male volunteers rather than in patients with a specific disease. Its intended therapeutic indications have not been disclosed, so no approved or established use exists for the compound.