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    A study to find out how safe is it to give people a new medicine called “GDC-8264” – including the effect of food on GDC-8264, and the effect of combining GDC-8264 with other medicines

    • Autoimmune Disorder
    • Inflammatory Bowel Disease (IBD)

    Basic Details

    Gender
    All
    Age
    18 to 55 Years
    Healthy Volunteers
    Yes
    Sponsor F. Hoffmann-La Roche Ltd (Switzerland), Genentech Inc (USA)
    Phase Phase 1
    Study Identifier GP41678

    Healthy volunteers for single ascending dose (SAD; n=38), multiple ascending dose (MAD; n=15), and drug-drug interaction (DDI; n=15) cohorts were enrolled at one study site in the Netherlands to evaluate the safety and tolerability of GDC-8264, with potential activity in patients with inflammatory bowel disease (IBD). All 68 healthy volunteers completed the study and comprised the safety-evaluable population. Results showed single and multiple doses of GDC-8264 taken by mouth were safe and well-tolerated. GDC-8264 can be taken with or without food. One type of measurement indicated DDI, while other measurements did not. There were no deaths or serious adverse events. No single study can tell us everything about the risks and benefits of a medicine. It takes lots of people in many studies to find out everything we need to know. The results from this study may be different from other studies with the same medicine.

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    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.