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RO7890597

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

RO7890597 · 1 trial · 1 indication

Phase 1 1
NCT07797478A Study of RO7890597 in Healthy Adult VolunteersHealthy Volunteers
RECRUITING139 Analytics
PHASE1RECRUITING
A Study of RO7890597 in Healthy Adult Volunteers
Healthy Volunteers
NCT07797478139
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Study Endpoints

Primary Endpoints

Incidence and Severity of Adverse Events (AEs)
Up to approximately 12 weeks

Secondary Endpoints

Plasma Concentration of RO7890597
At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Under Fasted and Fed Conditions
At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole
At prespecified timepoints from baseline up to approximately 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
RO7890597EXPERIMENTALParticipants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.
PlaceboEXPERIMENTALParticipants will receive single or multiple doses of matching placebo.

Interventions

NameTypeDescription
RO7890597DRUGParticipants will receive RO7890597 as per the schedule described in the protocol.
PlaceboDRUGParticipants will receive matching placebo as per the schedule described in the protocol.
RabeprazoleDRUGParticipants will receive rabeprazole as per the schedule described in the protocol.
ItraconazoleDRUGParticipants will receive itraconazole as per the schedule described in the protocol.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Agreement to adhere to the contraception requirements. * Body mass index of 18 to 30 kilograms per square meter (kg/m²). Exclusion Criteria: * Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period. * Treatment with investi...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT07797478NEW_TRIAL: changed
LOWSep 1, 2026NCT07797478NEW_TRIAL: changed