Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma
Status:
Completed
Trial end date:
2020-10-26
Target enrollment:
Participant gender:
Summary
In both parts, the primary comparisons of interest are between the percentage of patients
with drug-related adverse events at each dose and placebo during single and multiple dosing
regimens. Based on these, the primary trial objective is to assess safety and tolerability of
BI 894416 at each dose.
Secondary measures of interest are the geometric means of BI 894416 plasma AUC0-∞ and Cmax
after single dose in SRD part and AUC0-8 and Cmax after single dose as well as AUCτ,ss and
Cmax,ss after 7 days multiple dosing in MRD part. The objective is to assess the
pharmacokinetics of BI 894416 following single and multiple administration.