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

  • Cancer - RET positive
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

GP43162

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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 Trial 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.

      Trial 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 Trial 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

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