How does the body process a cancer medicine (pralsetinib) – when it is taken together with another medicine (cyclosporine)

  • Cancer
  • Cancer - RET positive
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:

GP43162

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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 a medicine called, “pralsetinib”, for the treatment of patients with some types of cancer. The main questions were 1) What was the the effect of a single dose of cyclosporine on a single dose of pralsetinib? 2) How safe was it to give pralsetinib with cyclosporine – in comparison to giving pralsetinib alone? Fifteen healthy people took part in this study at one study center in one country.

      F. Hoffmann-La Roche Ltd (Switzerland) Sponsor
      Phase 1 Phase
      GP43162 Study Identifier
      All Gender
      18 to 55 Years Age
      Yes Healthy Volunteers

      Fifteen healthy volunteers were enrolled at one study site in USA to evaluate the effect of coadministration of cyclosporine on the pharmacokinetics of pralsetinib in healthy males and females of non-childbearing potential. Thirteen participants completed the study. Results showed that coadministration of cyclosporine and pralsetinib increased exposure to pralsetinib and increased the highest concentration of pralsetinib reached post-dosing. There were no deaths or serious side effects. The data from this study will help support further development of pralsetinib.

      Study Summary

      This clinical trial was done to study a medicine called, “pralsetinib”, for the treatment of patients with some types of cancer. The main questions were 1) What was the the effect of a single dose of cyclosporine on a single dose of pralsetinib? 2) How safe was it to give pralsetinib with cyclosporine – in comparison to giving pralsetinib alone? Fifteen healthy people took part in this study at one study center in one country.

      F. Hoffmann-La Roche Ltd (Switzerland) Sponsor
      Phase 1 Phase
      GP43162 Study Identifier
      Pralsetinib Treatments
      Cancer - RET positive Condition
      Official Title

      A phase 1, open-label, fixed-sequence study to evaluate the effect of a single dose of cyclosporine on the single dose pharmacokinetics of pralsetinib in healthy subjects

      Eligibility Criteria

      All Gender
      18 to 55 Years Age
      Yes Healthy Volunteers

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

       

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