The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects. The primary objective is to investigate the safety and tolerability of treatment with BI 661051. The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal. Pharmacodynamic parameters will not be determined within this study.
Purpose:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
64
medium dose solution for oral administration
medium dose solution for oral administration
medium dose solution for oral administration
low dose solution for oral administration
low dose solution for oral administration
low dose solution for oral administration
high dose solution for oral administration
high dose solution for oral administration
low dose tablet
solution for administration
medium dose tablet
1296.1.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Occurrence of findings of physical examination
Time frame: 14 weeks
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
Time frame: 14 weeks
Orthostasis test parameters
Time frame: 14 weeks
Body temperature
Time frame: 14 weeks
12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
Time frame: 14 weeks
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
Time frame: 14 weeks
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
Time frame: 14 weeks
Occurrence of findings detected by the pupillometry measurements
Time frame: 14 weeks
Tolerability assessed by investigator
Time frame: 14 weeks
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 14 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 14 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)
Time frame: 14 weeks
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 14 weeks
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