A study to find out what happens to a new medicine (inavolisib) inside the human body

  • Cancer
  • Breast Cancer
  • Breast Cancer HER-2 Positive
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

GP42652

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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 trial 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

      Trial Summary

      This clinical trial was done to study a new medicine called, “inavolisib”, for the treatment of patients with cancer. The main questions that researchers wanted to answer included 1) how much inavolisib was removed from the body and through which route was it removed from the body; 2) how much inavolisib was available in the blood when taken as a 9 mg capsule. Eight healthy people took part in this study at one study center in one country.

      Genentech, Inc. (USA) Sponsor
      Phase 1 Phase
      GP42652 Trial Identifier
      All Gender
      18 to 65 Years Age
      Yes Healthy Volunteers

      Eight healthy volunteers were enrolled at one study site in USA to evaluate the bioavailability, metabolism, and excretion of inavolisib, a small molecule inhibitor of the Class I PI3Kα isoform and with increased potency in PI3K with mutated p110α. All 8 participants completed the study. Results showed inavolisib was removed from the body through passing urine and feces, and the bioavailability of the oral capsule was 76%. There were no deaths or serious AEs. The data from this study will help support further development of inavolisib.

      Trial Summary

      This clinical trial was done to study a new medicine called, “inavolisib”, for the treatment of patients with cancer. The main questions that researchers wanted to answer included 1) how much inavolisib was removed from the body and through which route was it removed from the body; 2) how much inavolisib was available in the blood when taken as a 9 mg capsule. Eight healthy people took part in this study at one study center in one country.

      Genentech, Inc. (USA) Sponsor
      Phase 1 Phase
      GP42652 Trial Identifier
      Inavolisib (GDC-0077) Treatments
      Breast Cancer HER-2 Positive Condition
      Official Title

      A phase 1, open-label, single-center, study to investigate the absorption, metabolism, excretion, and absolute bioavailability of a single oral dose of [¹⁴C]-labeled inavolisib and IV tracer dose of [¹³C₆]-labeled inavolisib in a single cohort of healthy volunteers

      Eligibility Criteria

      All Gender
      18 to 65 Years Age
      Yes Healthy Volunteers

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

       

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