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
Completed
GA41335
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.
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.
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
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