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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
BI 894416 film-coated tablet.
Placebo film-coated tablet matching BI 894416.
Fraunhofer ITEM
Hanover, Germany
Percentage of Patients With Treatment-emergent Adverse Events Related to BI 894416
Percentage of patients with treatment-emergent adverse events (AEs) related to BI 894416.
Time frame: From start of treatment till the end of trial, up to 30 days.
AUC0-∞ (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) of BI 894416 (SRD Part)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 894416 (single rising dose part).
Time frame: 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment.
Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 (SRD Part)
Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 (single rising dose part).
Time frame: 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment.
AUC0-8 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 8 Hours) of BI 894416 After the First Dose (MRD Part)
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) of BI 894416 after the first dose (Multiple rising dose part).
Time frame: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours following first dose (day 1).
Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 After the First Dose (MRD Part)
Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 after the first dose (Multiple rising dose part).
Time frame: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23.92 hours following first dose (day 1).
AUCtau,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part)
AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part).
Time frame: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9).
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part).
Time frame: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9).
Difference From Baseline in Airway Resistance (RAW) After 7 Days of Treatment (MRD Part)
Difference in airway resistance (RAW) from baseline (measured on day 1) to day 9, after 7 days (day 2-8) of t.i.d. (three times daily) treatment.
Time frame: Up to 9 days.
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