As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
1284.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Safety and tolerability (number and intensity of adverse events).
Time frame: 4 months
Changes in blood pressure.
Time frame: 4 months
Changes in pulse rate.
Time frame: 4 months
Changes in respiratory rate.
Time frame: 4 months
Changes in 12-lead ECG.
Time frame: 4 months
Changes in clinical laboratory test parameters.
Time frame: 4 months
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 3 days
tmax (time from dosing to maximum measured concentration)
Time frame: 3 days
AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 3 days
t1/2 (terminal half-life of the analyte in plasma)
Time frame: 3 days
MRT (mean residence time of the analyte in the body after drug intake)
Time frame: 3 days
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
50 mg oral drinking solution
100 mg oral drinking solution
150 mg oral drinking solution
200 mg oral drinking solution
400 mg oral drinking solution
600 mg oral drinking solution
10,0 mg immediate release tablet
50,0 mg immediate release tablet
matching placebo (oral drinking solution and IR tablets)
Time frame: 3 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Time frame: 3 days
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 3 days
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 3 days
CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: 3 days