A study to find out what happens to a new study medicine (GDC-0214) when it is breathed in (inhaled) into the lungs

Open-label, uncontrolled, non-randomized, single-dose, scintigraphic study to investigate lung deposition of inhaled 99mTc radiolabeled GDC-0214 DPI in healthy adult volunteers

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Cities
Trial Identifier:

GA41335

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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.

      Results Disclaimer

      Trial Summary

      Healthy volunteers (n=12) were enrolled at one study site in the United Kingdom to investigate lung deposition of inhaled 99mTc radiolabeled GDC-0214 DPI, a small molecule inhibitor of JAK1. All 12 participants completed the study and comprised the safety-evaluable population. Results showed GDC-0214 to be well tolerated; there were no deaths, SAEs or AEs related to GDC-0214, and no discontinuations or modifications of the study treatment. GDC-0214 that was released (emitted) from the inhaler was deposited in the lungs (~50%) and oropharynx + stomach (~49%). About 15% of the dose loaded into the inhaler remained in the chamber and 3% remained in the mouthpiece.

      Genentech Sponsor
      GA41335 Trial Identifier
      All Gender
      28 to 60 Years Age
      Yes Healthy Volunteers

      This clinical trial was done to study a new medicine called, “GDC-0214”, for the treatment of patients with asthma. This study was done to find out what happens to a new study medicine when it is breathed in (inhaled) into the lungs. Twelve healthy people took part in this study at one study center in one country.

      Trial Summary

      Healthy volunteers (n=12) were enrolled at one study site in the United Kingdom to investigate lung deposition of inhaled 99mTc radiolabeled GDC-0214 DPI, a small molecule inhibitor of JAK1. All 12 participants completed the study and comprised the safety-evaluable population. Results showed GDC-0214 to be well tolerated; there were no deaths, SAEs or AEs related to GDC-0214, and no discontinuations or modifications of the study treatment. GDC-0214 that was released (emitted) from the inhaler was deposited in the lungs (~50%) and oropharynx + stomach (~49%). About 15% of the dose loaded into the inhaler remained in the chamber and 3% remained in the mouthpiece.

      Genentech Sponsor
      GA41335 Trial Identifier
      GDC-0214 Treatments
      None for healthy volunteers Condition
      Official Title

      Open-label, uncontrolled, non-randomized, single-dose, scintigraphic study to investigate lung deposition of inhaled 99mTc radiolabeled GDC-0214 DPI in healthy adult volunteers

      Eligibility Criteria

      All Gender
      28 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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