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A study to find out if taking different forms of a medicine (GDC-6036) results in the same amount of medicine in your body – and the effect of food on the medicine
A Phase 1, Open-Label, Single-Dose, Randomized, Three-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of GDC-6036 in Healthy Subjects
Cancer Lung Cancer Non-Small Cell Lung Cancer (NSCLC)
Basic Details
Male and Female
18 to 60 Years old
Yes
Sponsor
Genentech, Inc. (Part of F. Hoffmann-La Roche Ltd., Switzerland)
Phase
Phase 1
Study Identifier
GP43039
Healthy volunteers were enrolled at one study site in USA to evaluate the relative bioavailability of tablet and capsule formulations, and the effect of food, on GDC-6036. Seventeen participants enrolled in the phase 1, open-label, randomized, three-period crossover, single-dose study. Results showed the capsule and tablet formulations to have similar bioavailability. Taking GDC-6036 after a meal slowed down the absorption rate and lowered the peak concentration reached – in comparison to taking GDC-6036 on an empty stomach. Study results will support other ongoing studies on GDC-6036, a KRAS G12C inhibitor.
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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For the latest version of this information please go to www.forpatients.roche.com