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RG1662 granules

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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

RG1662 granules · 1 trial · 1 indication

Phase 1 1
NCT02194244Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662Healthy Volunteer
COMPLETED18 Analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
Up to 9 weeks
Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
Up to 9 weeks
Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
Up to 9 weeks
Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
Up to 9 weeks

Secondary Endpoints

Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
Up to 9 weeks
Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
Up to 9 weeks
Palatability of the granule formulation, as assessed by questionnaire
Day 1, Day 3 in granule administration periods
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Granules FastedEXPERIMENTAL -
Granules FedEXPERIMENTAL -
Tablet FastedACTIVE_COMPARATOR -
Tablet FedACTIVE_COMPARATOR -

Interventions

NameTypeDescription
RG1662 granulesDRUGSingle dose, oral administration of RG1662 immediate release granules
RG1662 tabletDRUGSingle dose, oral administration of film-coated RG1662 immediate release tablet
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female volunteers, 18 to 60 years of age, inclusive Exclusion Criteria: * A history of epilepsy, convulsions or significant head injury * Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Countries:United Kingdom
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Frequently asked questions about RG1662 granules

What is RG1662 granules used for?

RG1662 granules is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its bioavailability compared to a film-coated tablet formulation. The drug is being developed by Roche Holding AG.

Who makes RG1662 granules?

RG1662 granules is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 clinical trial to compare the bioavailability of the granule formulation with a film-coated tablet version of RG1662.

What phase is RG1662 granules in?

RG1662 granules is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 18 healthy volunteers in the United Kingdom. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RG1662 granules in?

RG1662 granules has one completed clinical trial, NCT02194244, titled 'Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662'. This Phase 1 study enrolled 18 healthy volunteers in the United Kingdom and was active-controlled, though not double-blinded.

Is RG1662 granules the same as RG1662?

RG1662 granules is a formulation of the investigational drug RG1662. The granule form was studied in a Phase 1 trial to compare its bioavailability with the film-coated tablet formulation of RG1662. Both are being developed by Roche Holding AG.