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RO6799477

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Jun 14, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

RO6799477 · 2 trials · 2 indications

Phase 1 2
NCT02164266A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477Healthy Volunteer, Type 2 Diabetes
COMPLETED40 Analytics
NCT01893437A Study of RO6799477 in Healthy VolunteersHealthy Volunteer
COMPLETED27 Analytics
PHASE1COMPLETED
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
Healthy Volunteer, Type 2 DiabetesUnlock trial analytics
PHASE1COMPLETED
A Study of RO6799477 in Healthy Volunteers
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 9 weeks
Part 1: Safety: Incidence of adverse events
18 weeks

Secondary Endpoints

Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax
Day 1 and Day 14
Fasting serum glucose
Up to 9 weeks
Fasting serum insulin (Part 2 only)
Up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Healthy VolunteersEXPERIMENTAL -
Part 2: Patients with T2D, Group AEXPERIMENTALLow dose daily oral administration of RO6799477
Part 2: Patients with T2D, Group BEXPERIMENTALHigh dose daily oral administration of RO6799477
Single oral dose groupEXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo daily oral administration
RO6799477DRUGDaily oral administration of RO6799477
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Part 1 Inclusion criteria: * Right-handed male volunteers * Aged 18-45 years, inclusive * Healthy participants, as determined by screening assessments and Principal Investigator's judgment * Healthy status is defined by the absence of evidence of any active or chronic disease f...

Countries:Netherlands
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Frequently asked questions about RO6799477

What is RO6799477 used for?

RO6799477 is an investigational small molecule being studied for use in healthy volunteers and in patients with Type 2 Diabetes. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.

Who makes RO6799477?

RO6799477 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule currently in Phase 1 clinical trials.

What phase is RO6799477 in?

RO6799477 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are being conducted to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is RO6799477 in?

RO6799477 has been studied in two completed Phase 1 clinical trials: NCT01893437, which enrolled 27 healthy volunteers in the Netherlands, and NCT02164266, which enrolled 40 participants including healthy volunteers and patients with Type 2 Diabetes. Both trials were completed.

Is RO6799477 the same as any other drug?

No alternative names for RO6799477 have been disclosed. The drug is identified solely by its code name RO6799477 in clinical trial records.