A study to find out if people get the same amount of medicine (alectinib) - when they take different forms of the medicine - with or without food.

A randomized, open-label, two-treatment, two-part, study to explore the performance of alectinib extemporaneous suspension on alectinib capsule bioavailability in healthy subjects in fed and fasted conditions.

  • Healthy Volunteers
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 Kingdom
Study Identifier:

GP42776

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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

      Healthy volunteers for Group 1 (n=14) and Group 2 (n=7 high fat meals; n=7 low fat meals) were enrolled at one study site in the United Kingdom to explore the relative bioavailability of alectinib from oral suspension and hard capsule formulation in healthy subjects under fasted (Group 1) and fed (Group 2) conditions. All 28 participants completed the study. Results showed an increase in alectinib systemic exposure for oral suspension compared to capsule, that was higher in the fed state than in the fasted state. Adverse events (AEs) regardless of attribution occurred in 11 subjects. Three subjects experience related AEs. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment.

      Genentech, Inc. Sponsor
      GP42776 Study Identifier
      All Gender
      18 to 60 Years Age
      Yes Healthy Volunteers

      This clinical trial was done to study a medicine called, “alectinib”, for the treatment of patients with cancer. This study investigated how much medicine was available in the body (relative bioavailability) in different formulations - when alectinib was taken as an oral suspension and as hard capsules - taken without food (Group 1) and with food (Group 2). Twenty-eight healthy people took part in this study in one country.

      Study Summary

      Healthy volunteers for Group 1 (n=14) and Group 2 (n=7 high fat meals; n=7 low fat meals) were enrolled at one study site in the United Kingdom to explore the relative bioavailability of alectinib from oral suspension and hard capsule formulation in healthy subjects under fasted (Group 1) and fed (Group 2) conditions. All 28 participants completed the study. Results showed an increase in alectinib systemic exposure for oral suspension compared to capsule, that was higher in the fed state than in the fasted state. Adverse events (AEs) regardless of attribution occurred in 11 subjects. Three subjects experience related AEs. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment.

      Genentech, Inc. Sponsor
      GP42776 Study Identifier
      Alectinib Treatments
      None for healthy volunteers Condition
      Official Title

      A randomized, open-label, two-treatment, two-part, study to explore the performance of alectinib extemporaneous suspension on alectinib capsule bioavailability in healthy subjects in fed and fasted conditions.

      Eligibility Criteria

      All Gender
      18 to 60 Years Age
      Yes Healthy Volunteers

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

       

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