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    Is it safe for people to take a new medicine (GDC-2394) – and how is the medicine is processed by the body

    • Cardiovascular Disorder
    • Cardiovascular Disease

    Basic Details

    Gender
    Male and Female
    Age
    18 to 65 Years old
    Healthy Volunteers
    Yes
    Sponsor Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
    Phase Phase 1
    Study Identifier GC42880

    Healthy volunteers were enrolled at one study site in New Zealand to evaluate the safety and tolerability of GDC-2394, an NLRP3 inhibitor. Sixty-seven participants enrolled in the phase 1, placebo-controlled and randomized, double-blind, dose-escalation study. Results showed that the concentration of GDC-2394 in the body increased when the dose taken was increased. There was not much difference in the concentration whether taken with food or on an empty stomach. GDC-2394 did not affect how a second medicine (midazolam) was processed by the body. Two of 67 people (3%) experienced serious side effects that the doctors believed to be related to GDC-2394. These side effects eventually resolved. This study was stopped and nobody was allowed any more GDC-2394 because of these serious side effects.

    This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

    The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      What is Clinical Research?

      In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

      For the latest version of this information please go to www.forpatients.roche.com