Healthy Volunteers
Conditions
Brief summary
This study will evaluate the safety, pharmacokinetics (PK), and activity of single and multiple doses of RO7890597 compared with placebo in healthy volunteers. The study includes single ascending dose (SAD) stage, multiple ascending dose (MAD) stage, food-effect and proton pump inhibitor (PPI) stages, and a supplemental drug-drug interaction (DDI) stage.
Interventions
DRUGRO7890597
Participants will receive RO7890597 as per the schedule described in the protocol.
DRUGPlacebo
Participants will receive matching placebo as per the schedule described in the protocol.
DRUGRabeprazole
Participants will receive rabeprazole as per the schedule described in the protocol.
DRUGItraconazole
Participants will receive itraconazole as per the schedule described in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
SAD and MAD stages: Double Blind Food-effect, PPI, and DDI stages: Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 investigational biologic therapy within 90 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with investigational non-biologic therapy within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with immunosuppressive medication within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation. * Treatment with any vaccine within 14 days prior to initiation of study drug, or within 28 days for a live or live attenuated vaccine. * Poor peripheral venous access. * Major surgery within 28 days before study drug initiation or planned major surgery during the study. * Current infection or recent infection requiring antibiotics as defined in the protocol. * History of malignancy within 5 years before screening, except for specified adequately treated cancers. * History of clinically significant drug or food allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events (AEs) | Up to approximately 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTReference Study ID Number: GA46708 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed