The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
single dose of matching placebo
single dose of low, medium or high dose of BI 135585 XX
1283.5.82001 Boehringer Ingelheim Investigational Site
Seoul, South Korea
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
Time frame: up to 21 days
Changes in 12-lead ECG (electrocardiogram)
Time frame: up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
Time frame: up to 21 days
Occurrence of Adverse events
Time frame: up to 21 days
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 10 days
Tmax (maximum measured concentration of the analyte in plasma)
Time frame: 10 days
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 10 days
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