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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
Male and Female
18 to 65 Years old
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.
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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