A study to find out how safe is it to give people a new medicine for asthma (GDC-4379), and to see how this medicine is processed in the body

Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled GDC-4379 conducted in three parts: A single-ascending dose study in healthy volunteers, a multiple-ascending dose study in healthy volunteers, and a proof-of-activity study in patients with mild asthma

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Cities
Trial Identifier:

GA41024

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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 for Parts A (n=48) and B (n=32), and asthma patients for Part C (n=48) were enrolled at two study sites in New Zealand to evaluate the safety and tolerability of GDC-4379, an inhibitor of JAK1. Part A was a single-ascending dose study (1–80 mg of GDC-4379). Parts B was a multiple-ascending dose study (3–80 mg QD). Part C was a proof of activity study (10–80 mg QD). Results showed GDC-0214 to be similarly tolerated in active and placebo dose groups. There were no deaths or serious side effects. One participant (Part B) stopped treatment due to a side effect. GDC-4379 showed some activity in reducing inflammation in patients with asthma. Based on this study, researchers decided not to develop GDC-4379 any further because the results showed that patients will need a very high dose of this medicine to control asthma.

      GA41024 Trial Identifier
      All Gender
      18 to 65 Years Age
      Yes Healthy Volunteers

      This clinical trial was done to study a new medicine called, “GDC-4379”, for the treatment of asthma. This study investigated whether it was safe to give people single and multiple doses of GDC-4379. Researchers also wanted to find out what happened to GDC-4379 in the body, and if there was any indication that GDC-4379 may be useful in patients with asthma. One hundred and twenty-eight healthy people and patients with asthma took part in this study at two study centers in one country.

      Trial Summary

      Healthy volunteers for Parts A (n=48) and B (n=32), and asthma patients for Part C (n=48) were enrolled at two study sites in New Zealand to evaluate the safety and tolerability of GDC-4379, an inhibitor of JAK1. Part A was a single-ascending dose study (1–80 mg of GDC-4379). Parts B was a multiple-ascending dose study (3–80 mg QD). Part C was a proof of activity study (10–80 mg QD). Results showed GDC-0214 to be similarly tolerated in active and placebo dose groups. There were no deaths or serious side effects. One participant (Part B) stopped treatment due to a side effect. GDC-4379 showed some activity in reducing inflammation in patients with asthma. Based on this study, researchers decided not to develop GDC-4379 any further because the results showed that patients will need a very high dose of this medicine to control asthma.

      GA41024 Trial Identifier
      GDC-4379 Treatments
      None for healthy volunteers Condition
      Official Title

      Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled GDC-4379 conducted in three parts: A single-ascending dose study in healthy volunteers, a multiple-ascending dose study in healthy volunteers, and a proof-of-activity study in patients with mild asthma

      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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