Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG1662 granules · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Granules Fasted | EXPERIMENTAL | - |
| Granules Fed | EXPERIMENTAL | - |
| Tablet Fasted | ACTIVE_COMPARATOR | - |
| Tablet Fed | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RG1662 granules | DRUG | Single dose, oral administration of RG1662 immediate release granules |
| RG1662 tablet | DRUG | Single dose, oral administration of film-coated RG1662 immediate release tablet |
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
RG1662 granules is an investigational small molecule developed by Roche Holding AG. It is a granule formulation of RG1662 that has been studied in a Phase 1 comparative bioavailability trial in healthy adult volunteers. The granules are one of two oral formulations of RG1662 evaluated in that study.
RG1662 granules is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 1 comparative bioavailability study of the granule and film-coated tablet formulations of RG1662 conducted in the United Kingdom.
RG1662 granules is in Phase 1 clinical development. One Phase 1 trial of the granule formulation has been completed, and no trials of RG1662 granules are currently active. The drug is investigational and has not been approved by the FDA for any indication.
RG1662 granules has been evaluated in one completed Phase 1 trial, NCT02194244, titled Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662. The trial enrolled 18 healthy adult volunteers in the United Kingdom, used an active-controlled design, and included randomization.
NCT02194244 was a completed Phase 1 comparative bioavailability study of the film-coated tablet and granule formulations of RG1662. It enrolled 18 healthy volunteers of all sexes, aged 18 years and older, in the United Kingdom. The study was randomized and active-controlled, and it was not double-blind.