Healthy
Conditions
Brief summary
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
Interventions
DRUGMatching placebo
single dose of matching placebo
DRUGBI 135585 XX
single dose of low, medium or high dose of BI 135585 XX
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male volunteers, 2. Chinese or Japanese ethnicity
Exclusion criteria
1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement 2. Any evidence of a clinically relevant concomitant disease 3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR)) | up to 21 days |
| Changes in 12-lead ECG (electrocardiogram) | up to 21 days |
| Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis) | up to 21 days |
| Occurrence of Adverse events | up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | 10 days |
| Tmax (maximum measured concentration of the analyte in plasma) | 10 days |
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 10 days |
Countries
South Korea
Outcome results
None listed