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)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Country
  • United States
Study Identifier:

GP43039

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

      Results Disclaimer

      Study Summary

      This clinical trial was done to study “GDC-6036”, a medicine for the treatment of patients with cancer. This phase 1 study investigated how much medicine was delivered to the body by the capsule and tablet forms – the relative bioavailability of GDC-6036. It also investigated whether there was a difference if GDC-6036 was taken after eating or on an empty stomach – the food effect on GDC-6036. Seventeen healthy men took part in this study at one study center in one country – the USA.

      Genentech, Inc. (Part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1 Phase
      GP43039 Study Identifier
      Male and Female Gender
      18 to 60 Years old Age
      Yes Healthy Volunteers

      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.

      Study Summary

      This clinical trial was done to study “GDC-6036”, a medicine for the treatment of patients with cancer. This phase 1 study investigated how much medicine was delivered to the body by the capsule and tablet forms – the relative bioavailability of GDC-6036. It also investigated whether there was a difference if GDC-6036 was taken after eating or on an empty stomach – the food effect on GDC-6036. Seventeen healthy men took part in this study at one study center in one country – the USA.

      Genentech, Inc. (Part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1 Phase
      GP43039 Study Identifier
      KRAS G12C inhibitor (GDC-6036) Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      A phase 1, open-label, single-dose, randomized, three-period crossover study to evaluate the relative bioavailability and food effects of GDC-6036 in healthy subjects

      Eligibility Criteria

      Male and Female Gender
      18 to 60 Years old Age
      Yes Healthy Volunteers

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

       

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