The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
1289.17.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Percentage of Subjects With Investigator Defined Drug-Related Adverse Events
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Maximum measured concentration of the BI 409306 in plasma (Cmax).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)
Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)
Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
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Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.